Control of semi-autonomous vehicles

ABSTRACT

Semi-autonomous vehicle apparatus which is controlled by a plurality of control sources includes a vehicle which may function autonomously and apparatus for control of the vehicle by either an onboard driver or a driver not situated onboard. The vehicle may also be controlled by an off-vehicle computational device. Hierarchy setting apparatus determines which one or combination of the possible control entities take priority. Persons using the apparatus are identified by either a password or, preferably by providing identification based on a biologic feature. Management of impaired vehicle operators is provided for.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/397,160, filed Jan. 3, 2017, which in turn, is a continuation-in-partof U.S. patent application Ser. No. 14/628,502, filed Feb. 23, 2015 (nowU.S. Pat. No. 9,533,161, issued Jan. 3, 2017), which in turn is adivision of U.S. patent application Ser. No. 12/763,949, filed Apr. 20,2010, published on Oct. 21, 2010 as U.S. Patent Publication No.US/2010/0268304, and now U.S. Pat. No. 8,655,450, issued Feb. 18, 2014.

The subject matter of this application is related to that of:

1) U.S. patent application Ser. No. 10/460,458, filed Jun. 11, 2003,published on Dec. 18, 2003 as U.S. Patent Publication No.US/2003/0233129, and now U.S. Pat. No. 7,277,752;

2) U.S. patent application Ser. No. 11/502,484, filed Aug. 10, 2006, andpublished on Feb. 22, 2007 as U.S. Patent Publication No.US/2007/0043585A1, and now U.S. Pat. No. 9,082,156;

3) U.S. patent application Ser. No. 11/893,897, filed Aug. 18, 2007, andpublished on Dec. 27, 2007 as U.S. Patent Publication No.US/2007/0299473 and now U.S. Pat. No. 7,769,465;

4) U.S. patent application Ser. No. 11/895,934, filed Aug. 28, 2007, andpublished on Mar. 6, 2008 as U.S. Patent Publication No.US/2008/0058884, and now U.S. Pat. No. 8,214,043;

5) U.S. patent application Ser. No. 11/805,268, filed May 22, 2007, andpublished on May 29, 2008 as U.S. Patent Publication No. US/2008/0122636and now U.S. Pat. No. 8,289,172;

6) U.S. patent application Ser. No. 12/154,079, filed May 19, 2008, andpublished on Dec. 4, 2008 as U.S. Patent Publication No. US/2008/0300659and now U.S. Pat. No. 8,473,065;

7) Provisional Patent Application 61/204,957, filed on Jan. 13, 2009;

8) Provisional Patent Application 61/214,096, filed Apr. 20, 2009;

9) U.S. patent application Ser. No. 12/657,155, filed Jan. 13, 2010, andpublished on Jul. 14, 2011 as U.S. Patent Publication No.US/2011/0172740, and now U.S. Pat. No. 9,545,520;

10) U.S. patent application Ser. No. 13/537,318, filed Jun. 29, 2012,and published on Nov. 22, 2012 as U.S. Patent Publication No.US/2012/0296381 and now U.S. Pat. No. 8,565,882;

11) U.S. patent application Ser. No. 13/840,021, filed Mar. 15, 2013,and published on Oct. 24, 2013 as U.S. Patent Publication No.US/2013/0282071, and now U.S. Pat. No. 8,706,225;

12) U.S. patent application Ser. No. 13/795,250, filed Mar. 12, 2013,and published on Aug. 29, 2013 as U.S. Patent Publication No.US/2013/0226265 and now U.S. Pat. No. 8,583,251; and

13) U.S. patent application Ser. No. 14/076,521, filed Nov. 11, 2013,and published on Apr. 17, 2014 as U.S. Patent Publication No.US/2014/0107733, and now U.S. Pat. No. 8,805,529.

This application claims priority from the aforementioned U.S.Provisional Application No. 61/214,096 and U.S. patent application Ser.No. 12/763,949, filed Apr. 20, 2010.

All of the aforementioned U.S. Patent and published Patent Applicationsare incorporated herein by reference.

BACKGROUND OF THE INVENTION

Implantable medical devices, though they may have complex decisionmaking algorithms do not always make medically optimal decisions. Someof the time, this is because they do not have access to enough clinicalinformation. At other times, it may be because they are not optimallyprogrammed. At still other times, it is because their operatingalgorithms are not capable of distinguishing between differentconditions (e.g. electromagnetic interference vs. broken lead wire vs.life threatening tachycardia, in a patient with an ICD). At yet othertimes, it may be because of a device malfunction.

Outside input to the IMD, either in the form of additional data aboutthe patient, or control signals which alter the functioning of the IMD,can address the aforementioned deficiencies of an IMD. The outsideinputs may originate from an external device, from the patienthimself/herself, or from a remotely located medical professional. Theinventions described in the specification herein present IMD systemswith such outside inputs.

The U.S. Pat. No. 7,277,752 describes an implantable defibrillator whichmay be controlled by a remote medical professional (“MP”). Two familiesof formats are discussed. In the first family of formats, the MP is theprimary controller; the ICD takes control if communications with the MPare inadequate. In the second family of formats, the ICD is the primarycontroller; the MP may take control of the ICD if he/she determines thatsuch control is necessary based on the analysis of ICD signalstransmitted to the MP. The specification discusses (a) providing meansfor the MP to preview an ICD therapy decision, (b) having the MPcommunicate with the patient to determine the appropriate choice oftherapy; and (c) ICD battery power conservation.

The U.S. patent application Ser. No. 11/502,484 discusses the remotecontrol of other types of IMDs using the same two formats as presentedin U.S. Pat. No. 7,277,752. Also discussed is (a) the filtering ofimplanted device information before it is presented to the MP; (b)sensor apparatus for external defibrillator devices; and (c) situatingthe MP in locations other than a central station—e.g. as a practitionerin a physician's office.

The U.S. patent application Ser. No. 11/893,897 presents the control ofan external defibrillator which has three operating modalities: (a)control by a remotely located medical professional, (b) control by anon-scene person, and (c) control by the logic circuitry within thedevice. It also presents remotely controlling and implantabledefibrillator with pacing capabilities.

The U.S. patent application Ser. No. 11/895,934 discusses the assemblyof a remotely controllable defibrillator or pacemaker system by (a)using (i) an unmodified cellular telephone as the communications device,to work in conjunction with (ii) an implanted defibrillator or pacemakerwhich can communicate with the cellular telephone; (b) using (i) amodified cellular telephone as the communications device, to work inconjunction with (ii) an implanted defibrillator or pacemaker which hasbeen adapted to communicate with the cellular telephone; or (c) using athree component system including (i) an adapter device; (ii) unmodifiedcellular telephone which communicates with the adapter device, and (iii)an implanted defibrillator or pacemaker which can communicate with theadapter.

The U.S. patent application Ser. No. 12/154,079 discusses four formatsfor the division of/sharing of control between an MP and an IMD'scontrolling circuits. It discusses a communications device which relaysinformation between the IMD and a central station, with the relay devicehaving patient inputs. It discusses formats for central stationnotification in a two-agent IMD system (i.e. IMD and MP). It discusses amedical expert device which may be used in conjunction with the humanmedical professional. It also discusses (a) four different IMD batterypower management arrangements; and (b) formats for limiting orterminating communications with a central station in the event of either(i) low IMD battery reserve; and/or (ii) non-dire treatmentcircumstances.

The U.S. Provisional Patent Application No. 61/204,957 presents a highlyflexible communications system for an IMD environment which includes theIMD and a variety of repeater devices including a patient device.Techniques of communication security are discussed for an IMD system.The granting of permission by a patient, allowing remote reprogrammingof the IMD is presented.

The U.S. patent application Ser. No. 11/805,268, discusses the divisionof control of an aircraft among (a) an onboard pilot who may beimpaired, (b) an autopilot/computerized flight management system, and(c) a remotely located pilot. The impaired pilot may be considered to beanalogous to any device or person in the currently considered IMD systemwhose function is less than optimal—e.g. the IMD or the patient. Theautopilot/computerized flight management system may be considered to beanalogous to any of the devices in the IMD system including the patientdevice, the medical expert device or even the IMD. The remote pilot maybe considered to be analogous to medical professional, since both arethe system entities with the highest level of competence. Managementalgorithms and logic structures are presented in this patent applicationwhich examine the distribution of control among the aforementionedentities, and which pertain to aircraft in particular and other “missioncritical devices” for which an imperfect performance by a controller maylead to a disaster.

The present application examines multi-entity control of an IMD, inwhich one of the entities is the IMD patient. Data from the patientpotentially expands the breadth of information in a way that allows forbetter decision making than is the case when data originates solely fromthe IMD sensors.

The current application presents an extension to the techniques used tomanage implantable medical device systems: The management ofsemi-autonomous vehicle systems. Both such systems comprise complexdevices that will fail from time to time. Both systems comprise deviceswherein a device failure can have serious and even catastrophicconsequences. Both systems include backup systems which themselves areerror prone/Both such systems involve a mixture of monitoring and actingby both human components and computational components. Both systemsinvolve the sharing of data among the entities to facilitate thatoversight of one entity by another.

SUMMARY OF THE INVENTION

The IMD system, according to the invention, comprises (i) an IMD, (ii)other outside agents which may control the IMD, one such agent being theIMD patient, and (iii) a device (the “patient device”) through which thepatient interacts with the IMD system.

Examples of systems which include the patient include:

-   -   (a) a 2-agent system comprising the IMD and the patient    -   (b) a 3-agent system comprising the IMD, the patient, and a        patient device    -   (c) a 3-agent system comprising the IMD the patient, and a        medical professional    -   (d) a 5-agent system comprising the IMD, the patient, a patient        device, a medical expert device and a medical professional, and    -   (e) a 7-agent system comprising an IMD with three control        algorithms, the patient, a patient device, a medical expert        device and a medical professional.        The medical professional is a human expert who may remotely        manage the IMD.

It is a principal object of the present invention to allow—in an IMDsystem that includes an IMD, a patient and a patient device—treatmentdecisions which can be based on inputs from the patient. In one format,the patient input is direct; The patient takes control of IMD:

-   -   (a) at his/her own initiative    -   (b) at the invitation of a device which is part of the system,        i.e.        -   (i) the IMD        -   (ii) the PT device, or        -   (iii) the ME device; or    -   (c) at the invitation of Medical Professional.        In another format, the patient input is indirect; Information        about the patient coming from a patient device is used to        control or assist in the control of the IMD. The patient device        assessment of the patient may be:    -   (a) cognitive, and/or    -   (b) physiologic        -   (i) via sensors attached to patient, and/or        -   (ii) via sensors in the vicinity of the patient.            Treatment decisions that may be made by the patient or by            the patient device include:    -   (a) overriding an IMD recommendation for treatment, thereby        withhold such treatment    -   (b) overriding an IMD recommendation for no treatment, thereby        causing such treatment    -   (c) taking control away from the IMD entirely    -   (d) returning control to the IMD (after having taken control        away)    -   (e) changing the programming of the IMD:        -   (i) its detection parameters        -   (ii) its treatment parameters, and/or        -   (iii) its parameters for notifying each of one or more other            devices or persons of a pre-specified medical state.

It is a further object of the present invention to back up patientcontrol in an IMD system with a “safety net,” i.e. having the patient'smanagement decisions overseen, either by

-   -   (a) a person—the MP, or    -   (b) a device:        -   i) the patient device, and/or        -   ii) the medical expert device.            In a preferred embodiment of the invention, one or more of            these entities may take control away from the patient, if            the patient is not performing at a level that is deemed            proper by the overseeing agent (i.e. the MP, the M.E.            device, etc.).

In an IMD system in which control of the treatment administered by theIMD may issue from any one of two or more systems, a hierarchicalapproach which sets forth which entity is in control under whichconditions is necessary. For example, in one operating modality, thepatient may be able to overrule the decision of the IMD, and the MP maybe able to overrule the decision of the patient. In more complexmodalities:

(a) there may be more entities, and a control hierarchy which indicateswhich entity is in control under which conditions;

(b) the list of possible control entities (in addition to the IMD) mayinclude:

-   -   (i) both persons and devices;    -   (ii) only devices, or    -   (iii) three or more persons (e.g. the patient, the MP, and the        patient's MD;

(c) one hierarchical structure may be in effect for certain conditions,and another hierarchical structure for others (e.g. an ICD which (i)operates autonomously for tachycardia rates between 160 and 220, (ii)allows MP intervention for tachycardias with rates greater than 220, and(iii) allows either MP or patient intervention for tachycardias withrates between 140 and 160 (with the MP having priority over thepatient).

It is a further object of the present invention to institute suchhierarchical structures.

The aforementioned logical structure addresses the question of whichentity may dominate which other entity. Additional logical structure isrequired to address:

-   -   (a) What are the conditions which trigger the transfer?    -   (b) Does such transfer always occur when the conditions are met,        or not always        -   If not always, what determines when transfer does occur?    -   (c) Can the rules be changed which specify the transfer        conditions?        -   If yes, who can change them, and how is such a change            executed?            A structure which allows optional transfer of control            involves notifying one entity (e.g. the patient) about the            conditions observed by another entity (e.g. the IMD) only            under certain circumstances. Thus such notification entails            signaling the possible new control source about a patient            condition, for which the new control source has the option            of taking control. By limiting the conditions for which            notification takes place, the patient, other persons and/or            devices are not burdened with information about routine            matters that the device may easily handle, and the device            power supply is not wasted, transmitting unimportant            information.

It is a further object of the present invention to provide a system ofcontrol sharing in an IMD system by utilizing selective notification ofthe non-IMD entities in the system.

The IMD system may be rendered more sophisticated by control structuresin which not only notification depends on patient condition, but returnof control (once it has been taken away), second notification (i.e.notification following return of control, which may have differentcriteria than [first] notification prior to return of control), andsecond return of control (i.e. return of control following secondnotification) also may occur and are also dependent on patientcondition. These features (first and second notification and first andsecond return of control) may be time dependent, as well as patientcondition dependent. It is a further object of the present invention toinclude such logical formats in the operating algorithms of its memberdevices.

It is a further object of the present invention to allow at least oneperson, at at least one time, to determine the details of theaforementioned hierarchical structure, and information sharingstructure. For example, the MP may initially set the system so thatunder certain circumstances, the patient is allowed to overrule certainIMD decisions; The MP may later determine that the patient should nothave such access (either temporarily or permanently) and reprogram thehierarchy accordingly. The MP (or other authorized person [e.g. thepatient's physician]) may, from time to time also reprogram:

-   -   (a) notification criteria    -   (b) return of control criteria    -   (c) second notification criteria, and    -   (d) second return of control criteria.

It is a further object of the current invention to provide a method

-   -   (a) of arithmetic blending of multiple types of parametric data        of various types, related to patient condition,    -   (b) of arithmetic blending of non-parametric types of data of        various types, related to patient condition, and    -   (c) of arithmetic blending of both parametric and non-parametric        data of various types;        wherein the blending method generates a numerical value which        may be used to estimate the severity of a patient condition.        This numerical method to measure severity of a medical        condition, referred to hereinbelow as “FUNCTION*” is used by the        IMD to determine whether:    -   (a) treatment may be necessary; and/or    -   (b) notification of one or more outside agents (e.g. the patient        or the MP) may be desirable.

An arithmetic structure FUNCTION* facilitates (a) the arithmeticblending of diverse parametric information; (b) the arithmetic blendingof diverse non-parametric information; and (c) the blending ofparametric with non-parametric information.

It is a further object of the current invention to provide a system inwhich an IMD, a patient device with patient sensors, and a patient canpool their information, to allow for better decision making than wouldbe the case with the use of information coming from only one of theaforementioned three sources. This pooling can be accomplished by:

-   -   (a) having the IMD send some or all relevant information to the        patient device;    -   (b) having the patient device send some or all relevant        information to the IMD;    -   (c) both (a) and (b); and/or    -   (d) formats in which some or all of the IMD information and the        patient device information is sent to a third entity which pools        and integrates the information.

It is a further object of the current invention to provide a system inwhich multiple algorithms may be utilized in parallel fashion tosimultaneously evaluate patient data. The algorithms may benon-identical because:

-   -   (a) there may be no unique best method of evaluating the        necessity and type of treatment for a given patient situation;        and/or    -   (b) each algorithm may have access to only a subset of all        relevant information needed to make the best decision or        recommendation.        The algorithms:    -   (a) may be all device based; or    -   (b) may include both device based inputs and human inputs.        Types of all device based algorithms include:    -   (a) multiple algorithms running on the microprocessor(s) of a        single IMD;    -   (b) two or more of:        -   (i) at least one IMD algorithm,        -   (ii) a patient device algorithm, and        -   (iii) a medical expert device algorithm.            In the algorithmic processing of information, one or more of            the aforementioned devices may be replaced by, or augmented            by a person, viz.:    -   (a) the patient    -   (b) the medical professional and/or    -   (c) the patient's physician.        Algorithms are provided which allow for:    -   (a) automatic processing of information in device-only        situations;    -   (b) processing of information in device-only situations in which        there are automatic components and in which there is also        person-based input (for selecting among non-agreeing        algorithms);    -   (c) processing of information in which there are device inputs        and one or more person inputs.

According to a particular feature of the present invention, a medicalexpert device is included in the IMD system, located remotely from theIMD, which may either take control of IMD function under certaincircumstances, or function in an advisory capacity. The medical expertdevice may have an extensive database, which may be used to augment thefunctioning of the IMD, the patient device, the patient and/or themedical professional.

It is a further object of the invention to provide a patient devicewhich not only communicates with the IMD, but may also:

(a) serve as a repeater/relay unit, linking the IMD and a remotelylocated medical professional, as described in U.S. patent applicationSer. No. 12/154,079; and/or

(b) serve as a cellular telephone device.

As will be seen from the following, the ability to reliably control socalled self driving cars, and, in particular so called semi-autonomousvehicles bears many similarities to the ability to reliably controlimplanted medical devices.

So called self driving cars are part of a class of autonomoustransportation vehicles that include other transportation modalities andvehicles including automobiles, trucks, rail vehicles, ships,submarines, aircraft and space vehicles. Each is equipped with sensorsto allow them to navigate an environment and computational devices toanalyze the sensor data and allow navigation along a route andcompensation for other vehicular traffic, non-vehicular objects, varyingroute conditions, etc.

Given the fallibility of such vehicles—accidents and at least onefatality have been reported in the case of self driving cars—it islogical to consider backup systems for the devices such as a humandriver, present in the vehicle to assist or intervene when necessary.Unfortunately, in the case of such two-entity systems (the “self-drivingcar” plus the human driver) each entity is fallible: i.e. the humandriver is also fallible, and is known to be subject to equallycatastrophic errors caused by fatigue and distraction. Such a vehicle,with multi-entity control system is referred to herein as asemi-autonomous vehicles, or “SAV”.

More complex SAV systems include additional layers of oversight. Aremote person-referred to herein as a traffic professional or “TP”, withtelemetry to and from the vehicle would be able to pilot the vehiclegiven adequate information from sensors from the vehicle. Such a TPmight be less likely to be subject to driver fatigue and distraction,but would not be immune from it. In the event of either vehiclemal-performance related to inadequacy to the “self driving” program orsensors, and in the event of an onboard driver also failing to performproperly, the TP could intervene and properly pilot the vehicle.Alternatively, a setup with only the SAV and a TP—i.e. without theonboard driver—would also provide backup to bolster and prevent SAVfailures.

Yet another component of a system for improving the function of SAVswould be a remote non-human driver. Such a computational device could bemore robust than the one onboard the SAV—large, computationally morepowerful and more expensive. It too would utilize telemetry from sensorsonboard the SAV for its input. It could also access information aboutother vehicles (both near the piloted SAV and otherwise), routeconditions, weather conditions, etc. Herein, such a device is referredto as a traffic expert device, “T.E. device” or T.E.D. systems with morethan one T.E. device are possible.

Thus SAV systems are possible with two, three or all four controlentities, i.e. (1) the SAV itself, (2) an onboard human driver, (3) aT.E. device and (4) a TP. Systems with more than one T.E. device or morethan one TP may have 5 or more possible control entities.

Many of the system features and advantages of the implantable medicaldevice systems presented herein are applicable and necessary for theoperation of a multi-control entity system as described hereinabove forthe control of SAVs. These include the setting of a control hierarchy,notification systems, and proper identification of persons using thesystems.

The setting of what is referred to herein as control hierarchy ismandatory for a system in which there are multiple possible sources ofcontrol signals. The hierarchy prioritizes the control signals. Forexample, in a three entity system, such possibilities could include:

an onboard human driver choice takes priority over (i.e. can over-rulethe decision of) a SAV choice; and

a remote TP takes priority over the onboard human driver.

The SAV choice referred to herein is a decision that the SAV hasenacted, or is about to enact, based on its own computational system,concerning any feature of management of the vehicle. For example, a SAVmay “decide” to accelerate a vehicle and be overruled by the humandriver.Alternatively, the 3 entity system could be set up with a differenthierarchy than that indicated above, i.e.

a TP choice takes priority over a SAV choice; and

an onboard human driver takes priority over the TP choice.

Clearly, as the number of possible control entities increases the numberof possible hierarchies increases quickly (i.e. as the factorial of thenumber of entities).

Since one hierarchy may not always be ideal, the need to program thehierarchy is real. For example, a fatigued human driver must be assigneda low priority, or be totally locked out of vehicle control. The systemsdescribed herein provide for such programming. In addition, they providefor determining who may perform such programming—both in terms of theirstatus within the system (e.g. TPs may have a higher level of authoritythan human drivers) and in terms of a need for proper identification ofsuch individuals. Passwords for users of the system are a minimum, butbetter still are the use of biologic identifiers. The use of suchidentifiers is described in U.S. Pat. Nos. 8,233,672, and 9,152,837 andin U.S. patent application Ser. Nos. 14/874,922 and 13/834,634 to Matos,which are herein fully incorporated by reference.

In order not to swamp/over-burden a TP or T.E. device with low levelmanagement issues, a notification system is provided, architecturallysimilar to that for remotely controlled medical devices as described inthe parent and related patents applications. The notification isprogrammable and determines the magnitude of deviation from a norm thatmust occur before an entity other than the SAV is notified. This allowsfor notification of the entities in the higher echelons of the system(e.g. the TP and T.E. device) when those lower echelon entities (i.e.the SAV or the human driver) are not performing properly.

The degree of deviation has been evaluated by a function referred toherein as “Function *”, which may be an means of quantifying a deviationfrom an acceptable norm or range of normals. Thus, in a simple caseFunction * may look at only vehicle speed; but in more complex casesFunction * could generate a value which incorporates speed, speed limit,road quality (wet or dry), driver alertness and traffic density, forexample.

Multiple algorithms running in parallel may allow more robust systemfunction. The algorithms may all run on the SAV processor(s), or may bedistributed among the SAV computational apparatus and one or more T.E.device processor(s). In addition, techniques are presented for blendingthe recommendations of different algorithms, rather than accepting asingle one.

According to a particular feature of the invention, an impaired humandriver—whether onboard the SAV, or functioning as a TP—is detectable andremediable. Control may be taken away from such an individual, and laterreturned. Yet another feature of the invention is a second removal ofcontrol from the human—with the second removal having a lower thresholdfor execution.

For a full understanding of the present invention, reference should nowbe made to the following detailed description of the preferredembodiments of the invention as illustrated in the following drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a block diagram showing system architectures for a systemwhich links an IMD and one or more of a patient, a patient device, amedical expert device, and a central station staffed by a medicalprofessional.

FIG. 1B is a block diagram showing a system architecture for a systemwith an IMD with 3 or more operating states, an external control stationand a state setting device.

FIG. 1C is a block diagram showing a system architecture for a systemwith an IMD, at least one external control station and at least onestate setting device.

FIG. 1D is a block diagram showing a system architecture for a systemwith an IMD, a local external control station and a remote externalcontrol station.

FIG. 1E is a block diagram showing a system architecture for a systemwith an IMD, and three external control stations.

FIG. 1F is a block diagram showing a system architecture for a systemwith an IMD, and at least two external control stations.

FIG. 2 is a representational diagram showing a system in which acommunications relay unit which links an IMD to a remote station allowsaccess to the system by a person at the site of the relay unit.

FIGS. 3A-3D are block diagrams showing possible system architectures inIMD systems with a patient device and one or more communication relayunits,

FIG. 4A is a block diagram showing module and system architecture for asystem which includes an IMD, a patient device and a medical expertdevice.

FIG. 4B is a block diagram showing system architecture for a systemwhich includes an IMD, at least one external control station and atleast one external command station, and which shows the exchange ofinformation-carrying signals between these structures.

FIG. 5 is a representational diagram showing a patient with one or moreIMDs and an array of sensors and a communication device for accessingthe IMD system.

FIG. 6 is a representational diagram of a patient communications device.

FIG. 7A is a block diagram of an IMD which can run multiple parallelalgorithms to make a treatment determination.

FIG. 7B is a block diagram of an IMD which can run an algorithm which isinputted by control signals from four different external sources and oneinternal source.

FIG. 8 is a block diagram showing information which may be transmittedby the IMD transmitter.

FIG. 9 is a block diagram showing information which may be received bythe patient device receiver.

FIG. 10 is a block diagram showing information which may be transmittedby the patient device transmitter.

FIG. 11 is a block diagram showing information which may be received bythe IMD receiver.

FIG. 12 is a block diagram illustrating the maintenance of a database ofelectrograms and/or data about patient-related events, and its use togenerate treatment instructions.

FIG. 13 illustrates a touch-sensitive programming and display screen forcontrolling the IMD system.

FIG. 14 illustrates a touch-sensitive programming and display screen forprogramming control hierarchy within the IMD system.

FIG. 15 illustrates a touch-sensitive programming and display screen forprogramming access to hierarch control within the IMD system.

FIG. 16 illustrates a touch-sensitive programming and display screen forprogramming an IMD whose function may be influenced by informationobtained by a patient device.

FIG. 17 illustrates a touch-sensitive programming and display screen forprogramming the mixing of information coming from a patient device.

FIG. 18 illustrates a touch-sensitive programming and display screen forprogramming cognitive evaluation of a patient with a patient device.

FIG. 19 illustrates a touch-sensitive programming and display screen forprogramming the blending of two or more patient-related inputs.

FIG. 20 illustrates a touch-sensitive programming and display screen forprogramming the management of data from individual sensors in a patientdevice.

FIG. 21 illustrates a touch-sensitive programming and display screen forthe detection of a syncopal event by a patient device.

FIGS. 22A and 22B illustrate the use of a mathematical entity whichmeasures patient condition to determine when an IMD notifies the patientand when the IMD notifies a medical professional.

FIG. 23 illustrates another use of a mathematical entity which measurespatient condition to determine when an IMD notifies a medicalprofessional for a first time, and when it notifies the medicalprofessional for a second time.

FIG. 24 illustrates yet another use of a mathematical entity whichmeasures patient condition to determine when an IMD notifies the patientand when the IMD notifies a medical professional.

FIG. 25 is a flow diagram showing use of cognitive information about thepatient by the IMD.

FIG. 26 is a flow diagram showing use of cognitive information about thepatient by the medical professional.

FIG. 27A is a table showing the elements in a variety of 2-, 3- and4-entity IMD systems.

FIG. 27B is a table showing the elements in a variety of 5-entity IMDsystems.

FIG. 27C is a 2×2 table showing the relationship of four operatingstates in an IMD which may be controlled both internally and externally.

FIG. 28 is a table which shows a taxonomy of some 2, 3 and 5 entity IMDsystems, classifying the algorithms shown in FIGS. 29 through 57,herein.

FIG. 29 is a flow diagram illustrating the control of a 3 entity IMDsystem, which may be controlled by each of an IMD, a patient and amedical professional.

FIG. 30 is another flow diagram illustrating the control of a 3 entityIMD system, which may be controlled by each of an IMD, a patient and amedical professional.

FIG. 31 is another flow diagram illustrating the control of a 3 entityIMD system, which may be controlled by each of an IMD, a patient and amedical professional.

FIG. 32 is another flow diagram illustrating the control of a 3 entityIMD system, which may be controlled by each of an IMD, a patient and amedical expert device.

FIG. 33 is another flow diagram illustrating the control of a 3 entityIMD system, which may be controlled by each of an IMD, a patient and amedical professional.

FIG. 34 is another flow diagram illustrating the control of a 3 entityIMD system, which may be controlled by each of an IMD, a patient and amedical professional.

FIG. 35 is another flow diagram illustrating the control of a 3 entityIMD system, which may be controlled by each of an IMD, a patient and amedical professional.

FIG. 36 is another flow diagram illustrating the control of a 3 entityIMD system, which may be controlled by each of an IMD, a patient and amedical professional.

FIG. 37 is another flow diagram illustrating the control of a 3 entityIMD system, which may be controlled by each of an IMD, a patient and amedical professional.

FIG. 38 is a flow diagram illustrating the control of a 3 entity IMDsystem, which may be controlled by each of an IMD, a patient device anda patient.

FIG. 39 is another flow diagram illustrating the control of a 3 entityIMD system, which may be controlled by each of an IMD, a patient deviceand a patient.

FIG. 40 is another flow diagram illustrating the control of a 3 entityIMD system, which may be controlled by each of an IMD, a patient deviceand a patient.

FIG. 41 is another flow diagram illustrating the control of a 3 entityIMD system, which may be controlled by each of an IMD, a patient deviceand a patient.

FIG. 42 is another flow diagram illustrating the control of a 3 entityIMD system, which may be controlled by each of an IMD, a patient deviceand a patient.

FIG. 43 is another flow diagram illustrating the control of a 3 entityIMD system, which may be controlled by each of an IMD, a patient deviceand a patient.

FIG. 44 is a flow diagram illustrating the control of a general 3 entityIMD system, which may be controlled by each of its entities.

FIG. 45 is another flow diagram illustrating the control of a general 3entity IMD system, which may be controlled by each of its entities.

FIG. 46 is a flow diagram illustrating the control of a 2 entity IMDsystem, which may be controlled by each of an IMD and a patient.

FIG. 47 is another flow diagram illustrating the control of a 2 entityIMD system, which may be controlled by each of an IMD and a patient.

FIG. 48 is another flow diagram illustrating the control of a 2 entityIMD system, which may be controlled by each of an IMD and a patient.

FIG. 49 is another flow diagram illustrating the control of a 2 entityIMD system, which may be controlled by each of an IMD and a patient.

FIG. 50 is a flow diagram illustrating the control of a 5 entity IMDsystem, which may be controlled by each of an IMD, a patient device, apatient, a medical expert device and a medical professional.

FIG. 51 is another flow diagram illustrating the control of a 5 entityIMD system, which may be controlled by each of an IMD, a patient device,a patient, a medical expert device and a medical professional.

FIG. 52 is another flow diagram illustrating the control of a 5 entityIMD system, which may be controlled by each of an IMD, a patient device,a patient, a medical expert device and a medical professional.

FIG. 53 is another flow diagram illustrating the control of a 3 entityIMD system, which may be controlled by each of an IMD, a patient and amedical professional.

FIG. 54 is another flow diagram illustrating the control of a 3 entityIMD system, which may be controlled by each of an IMD, a patient and amedical professional.

FIG. 55 is another flow diagram illustrating the control of a 3 entityIMD system, which may be controlled by each of an IMD, a patient and amedical professional.

FIG. 56A is another flow diagram illustrating the control of a 5 entityIMD system, which may be controlled by each of an IMD, a patient device,a patient a medical expert device, and a medical professional.

FIG. 56B is another flow diagram illustrating the control of a 5 entityIMD system, which may be controlled by each of an IMD, a patient device,a patient a medical expert device, and a medical professional.

FIG. 56C is another flow diagram illustrating the control of a 5 entitysystem, which may be controlled by each of its five constituententities.

FIG. 56D is another flow diagram illustrating the control of an N entitysystem, which may be controlled by each of its N constituent entities.

FIG. 57 is a flow diagram illustrating the operation of three parallelalgorithms, for management of sensor information in an IMD system.

FIG. 58 is a flow diagram illustrating the operation of two parallelalgorithms, for management of sensor information in an IMD system.

FIG. 59 is a flow diagram illustrating methods of shifting control of anIMD, in an IMD system.

FIG. 60 is another flow diagram illustrating methods of shifting controlof an IMD, in an IMD system.

FIG. 61 is another flow diagram illustrating methods of shifting controlof an IMD, in an IMD system.

FIG. 62 is another flow diagram illustrating methods of shifting controlof an IMD, in an IMD system.

FIG. 63 is another flow diagram illustrating methods of shifting controlof an IMD, in an IMD system.

FIG. 64 is another flow diagram illustrating methods of shifting controlof an IMD, in an IMD system.

FIG. 65 is another flow diagram illustrating methods of shifting controlof an IMD, in an IMD system.

FIG. 66 is another flow diagram illustrating methods of shifting controlof an IMD, in an IMD system.

FIG. 67 is another flow diagram illustrating methods of shifting controlof an IMD, in an IMD system.

FIG. 68 is another flow diagram illustrating methods of shifting controlof an IMD, in an IMD system.

FIG. 69 is another flow diagram illustrating methods of shifting controlof an IMD, in an IMD system.

FIG. 70 is another flow diagram illustrating methods of shifting controlof an IMD, in an IMD system.

FIGS. 71A-71F show graphic representations of some arithmeticrelationships illustrating possible formats for patient treatment, andpatient and/or medical professional notification in a 3-entity IMDsystem.

FIGS. 72A-72F show additional graphic representations of some arithmeticrelationships illustrating possible formats for patient treatment, andpatient and/or medical professional notification in a 3-entity IMDsystem.

FIGS. 73A-73C show additional graphic representations of some arithmeticrelationships illustrating possible formats for patient treatment, andpatient and/or medical professional notification in a 3-entity IMDsystem.

FIGS. 74A-74F show additional graphic representations of some arithmeticrelationships illustrating possible formats for patient treatment, andpatient and/or medical professional notification in a 3-entity IMDsystem.

FIGS. 75A-75F show additional graphic representations of some arithmeticrelationships illustrating possible formats for patient treatment, andpatient and/or medical professional notification in a 3-entity IMDsystem.

FIGS. 76A-76C show additional graphic representations of some arithmeticrelationships illustrating possible formats for patient treatment, andpatient and/or medical professional notification in a 3-entity IMDsystem.

FIG. 77 is a table showing a summary of examples illustrating controltransfer and entity interaction in the case histories illustrated inFIGS. 76-80.

FIG. 78 is a block diagram illustrating examples of the transfer ofcontrol of an implantable glucose control system, among an IMD, apatient, a patient device and a medical professional.

FIG. 79 is a block diagram illustrating an example of the interaction ofan implantable cardioverter defibrillator, a patient device, and amedical professional.

FIG. 80 is another block diagram illustrating an example of theinteraction of an implantable cardioverter defibrillator, a patientdevice, and a medical professional.

FIG. 81 is a block diagram illustrating examples of the interaction ofan implantable cardioverter defibrillator, a patient device, and amedical professional.

FIG. 82 is a block diagram illustrating examples of the interaction ofan implantable cardioverter defibrillator, a patient device, a patient,a medical expert device, and a medical professional.

FIG. 83 is a schematic diagram of a semi-autonomous vehicle.

FIG. 84A is a block diagram showing system architecture for SAVmanagement by multiple sources of control.

FIG. 84B is a block diagram of a SAV system with two or more sources ofcontrol.

FIG. 84C is a block diagram of a SAV system with at least one controldevice and at least one state setting device.

FIG. 84D is a block diagram of a SAV system with two additional sourcesof control, one local and one remote.

FIG. 84E is a block diagram of a SAV system with three additionalsources of control.

FIG. 84F is a block diagram of a generalized SAV system with anunspecified number of control stations.

FIG. 85 is a block diagram of a SAV.

FIG. 86 is a block diagram of a human driver unit within an SAV system.

FIG. 87 is a block diagram of a traffic expert (TE) unit within an SAVsystem.

FIG. 88 is a block diagram of a human traffic professional within theSAV system.

FIG. 89 is a block diagram of showing module and system architecture fora SAV system with SAV, an additional vehicle control unit and ahierarchy setting unit.

FIG. 90 is a representational diagram of a SAV system with monitoringdevices to determine the driver's fitness to drive.

FIG. 91 is a representational diagram of a SAV system with a drivercommunications device.

FIG. 92A is a block diagram of a SAV which can run multiple parallelalgorithms to make a management determination.

FIG. 92B is a block diagram of a SAV which receives control signals frommultiple external sources and one internal source.

FIG. 93 is a block diagram of information which may be transmitted bythe SAV transmitter.

FIG. 94 is a block diagram of information which may be received by theSAV receiver.

FIG. 95 is a block diagram of a database for managing a SAV system.

FIG. 96 is a programming and display screen for managing a SAV system.

FIG. 97 is a programming and display screen for managing hierarchywithin a SAV system.

FIG. 98 is a programming and display screen for managing hierarchycontrol within a SAV system.

FIG. 99 is a programming and display screen for assessing and managinghuman driver impairment within a SAV system.

FIGS. 100A and 100B illustrate the use of a mathematical entity whichmeasures SAV and driver condition to determine when a SAV notifies thedriver and when the SAV or driver notify a traffic expert orprofessional.

FIG. 101 is a flow diagram showing use of cognitive information aboutthe driver to determine SAV management.

FIG. 102 is another flow diagram showing use of cognitive informationabout the driver to determine SAV management.

FIGS. 103A and 103B are a table showing the elements in a variety of 2to 5 entity SAV systems.

FIG. 104A to 104C are 2×2 tables showing possible operating states in atwo control entity SAV system.

FIG. 105 is a flow diagram illustrating the control of a 2 entity SAVsystem, which may be controlled by each of an SAV and a human driver.

FIG. 106 is another flow diagram illustrating the control of a 2 entitySAV system, which may be controlled by each of a SAV and a human driver.

FIG. 107 is a flow diagram illustrating the control of a 3 entity SAVsystem, which may be controlled by each of a SAV, a traffic professionaland a human driver.

FIG. 108 is another flow diagram illustrating the control of a 3 entitySAV system, which may be controlled by each of a SAV, a trafficprofessional and a human driver.

FIG. 109 is yet another flow diagram illustrating the control of a 3entity SAV system, which may be controlled by each of a SAV, a trafficprofessional and a human driver.

FIG. 110 is a flow diagram illustrating the control of a 3 entity SAVsystem, which may be controlled by each of a SAV, a traffic expertdevice and a human driver.

FIG. 111 is yet another flow diagram illustrating the control of a 3entity SAV system, which may be controlled by each of a SAV, a trafficprofessional and a human driver.

FIG. 112 a flow diagram illustrating the control of a generalized3-entity SAV system, which may be controlled by any of the threeentities.

FIG. 113 another flow diagram illustrating the control of a generalized3 entity SAV system, which may be controlled by any of the threeentities.

FIG. 114 is a flow diagram illustrating the control of a 4 entity SAVsystem, which may be controlled by a SAV, a human driver a non-humantraffic expert device or a human traffic professional.

FIG. 115 is another flow diagram illustrating the control of a 4 entitySAV system, which may be controlled by a SAV, a human driver a non-humantraffic expert device or a human traffic professional.

FIG. 116 is yet another flow diagram illustrating the control of a 4entity SAV system, which may be controlled by a SAV, a human driver anon-human traffic expert device or a human traffic professional.

FIG. 117 is a flow diagram illustrating the control of a 3 entity SAVsystem, which may be controlled by a SAV, a human driver a human trafficprofessional.

FIG. 118 is another flow diagram illustrating the control of a 3 entitySAV system, which may be controlled by a SAV, a human driver a humantraffic professional.

FIG. 119 is yet another flow diagram illustrating the control of a 3entity SAV system, which may be controlled by a SAV, a human driver ahuman traffic professional.

FIG. 120A is a flow diagram illustrating the control of a 4 entity SAVsystem, which may be controlled by a SAV, a human driver a non-humantraffic expert device or a human traffic professional.

FIG. 120B is another flow diagram illustrating the control of a 4 entitySAV system, which may be controlled by a SAV, a human driver a non-humantraffic expert device or a human traffic professional.

FIG. 120C is yet another flow diagram illustrating the control of a 5entity generalized system, which may be controlled by any of the fiveentities.

FIG. 120D is yet a flow diagram illustrating the control of a N entity,which may be controlled by any of its entities.

FIG. 121 is a flow diagram illustrating the operation of three parallelalgorithms, for management of an SAV.

FIG. 122 is a flow diagram illustrating the operation of two parallelalgorithms, for management of an SAV.

FIG. 123 is a flow diagram illustrating the shifting of control from andback to an SAV.

FIG. 124 is another flow diagram illustrating the shifting of controlfrom and back to an SAV.

FIG. 125 is a flow diagram illustrating the shifting of control from andback to an SAV, followed by repeated taking of control away from theSAV.

FIG. 126 is a flow diagram illustrating the repeated shifting of controlfrom and back to an SAV.

FIGS. 127A to 127F show graphic representations illustrating thedistribution of information and of management among multiple entities ina SAV system.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Contents andAssociated Figures: 1.0 System Overview FIGS. 1A-1F 2.0 Hardware FIGS.2-12 3.0 Management Control Screens FIGS. 13-21 4.0 Triaging UsingFunction* FIGS. 22A-24 5.0 Patient Assessment Algorithms FIGS. 25-26 6.0System Architecture Summary FIGS. 27A-27C 7.0 System ManagementAlgorithms, overview FIG. 28 7.1 3-Entity Systems with IMD, Patient AndMedical Professional FIGS. 29-37 7.2 3-Entity Systems with IMD, Patientand Patient Device FIGS. 38-43 7.3 Generalized 3-Entity Systems FIGS.44-45 7.4 2-Entity Systems with IMD and Patient FIGS. 46-49 7.5 5-EntitySystems with IMD, Patient Device, Patient, Medical Expert Device AndMedical Professional FIGS. 50-52 7.6 Alternate 3-Entity System with IMD,Patient and Medical Professional FIG. 53 7.7 Second Alternate 3-EntitySystem with IMD, Patient and Medical Professional FIGS. 54-55 7.8Alternate > or =5-Entity Systems with IMD, Patient Device, Patient,Medical Expert Device and Medical Professional FIGS. 56A-56D 7.9Blending of Two or More Analysis or FIGS. 57-58 Control Algorithms 7.10Control Handoff Algorithms 7.10.1 Takeover and Return of Control FIGS.59-62 7.10.2 Takeover #2 FIGS. 63-65 7.10.3 Return of Control #2 FIGS.66-67 7.10.4 Time Dependent Formats FIGS. 68-70 8.0 Use of Function* forTriage 8.1 2 Zone Formats FIGS. 71-73 8.2 3 Zone Formats FIGS. 74-76 9.0Clinical Examples, overview FIG. 77 9.1 Blood Sugar Management FIG. 789.2 Ventricular Tachycardia Management FIGS. 79-82

1.0 System Overview

As used hereinafter, the term “personal medical device” (PMD) refers toa medical device capable of treating a patient which either: (a) isimplanted inside the body; (b) is attachable to the body and outside ofthe body; (c) is partially implanted in the body, or (d) consists ofsubunits, at least one of which is inside the body, and at least one ofwhich is outside the body.

FIG. 1A shows a schematic representation of an IMD system which includesa patient 100 with an IMD 102, and additional potentially interactingsystem devices and persons. The broken lines in the figure indicate that

(a) each of (i) the IMD, (ii) the patient device 104, (iii) a medicalexpert logic device 106, and (iv) a medical professional 108 in a remotestation 110, may communicate with each other; and

(b) the patient may communicate (i) directly, with the patient device,and (ii) via the patient device, with each of the IMD, the medicalexpert logic device and the medical professional.

The broken line between the IMD and the patient indicates that the IMDis implanted in the patient, provides treatment to the patient, mayreceive physiologic information about the patient through sensors andmay directly notify the patient of certain events by either emitting atone, or producing a vibrating motion. The IMD may be an implantabledefibrillator, a pacemaker, an insulin pump, an implantable druginfusion pump in general, a left ventricular assist device, animplantable heart, a brain or nerve stimulating device, a device forcontrolling blood pressure by stimulating carotid artery receptors, andin general, a device which is similar to that shown in FIG. 1 of U.S.Patent Application 20080300659 by Matos. The IMD in the figure containsboxes which indicate the possibility of running more than onesimultaneous operating algorithm (discussed hereinbelow in conjunctionwith FIG. 7), but IMDs which run a single algorithm are applicable aswell.

The IMD may function autonomously. Alternatively, it may be controlledby the patient device, the patient, the M.E. device or the medicalprofessional. There may be circumstances where control by one of theseagents is advantageous over autonomous control by the IMD or control bythe other agents. Examples are given and discussed hereinbelow inconjunction with FIGS. 78-82. Control of the IMD may be real time (e.g.the MP causes an ICD to provide antitachycardia pacing (“ATP”)), or maybe via a command which affects the future performance of the IMD (e.g.reprogramming the IMD to allow patient control under certaincircumstances).

The patient device (further described hereinbelow in conjunction withFIG. 6) allows:

-   -   (a) the patient, under certain circumstances, to control some or        all functions of the IMD;    -   (b) the IMD to provide information to the patient, including        information which may be useful for the patient to control the        IMD;    -   (c) the patient to communicate with the M.E. device;    -   (d) the patient to communicate with the MP;    -   (e) any of the IMD, the patient device, the M.E. device or the        MP to obtain information about the patient (either physiologic        or cognitive), which facilitates the control of the IMD; and    -   (f) control of the IMD by the patient device.

The M.E. device is an automated device for providing expert medicalguidance. The advantage of the M.E. device over the logic circuits ofthe IMD and/or the patient device, is the ability to draw on a largedatabase of information which may be useful for decision making. TheM.E. device may have a collegial relationship with the MP, in which thedevice and the human MP compare evaluations and potential therapeuticplans. The M.E. device may also be used to evaluateexperimental/investigational algorithms, and to evaluate and developneural network-based approaches. It is further discussed hereinbelow inconjunction with FIG. 12, and in other sections.

The MP, a human medical professional with expertise in the management ofthe IMD and of the condition which it treats, may access the informationprovided by (a) the IMD, (b) the patient, (c) the patient device, and(d) the M.E. device; and, if he chooses to, may provide control signalsto the IMD. Alternatively the MP may designate one of the other entities(i.e. the M.E. device, the patient device, or the patient) as theappropriate source of control, or may decide that the IMD should be thesource of control. Some system architectures do not have an MP; Stillother architectures include the MP on a selective basis, i.e. whencertain medical states occur, the MP is notified and is thereby invitedto participate. The MP may be (a) located in a central station whichcontrols many IMDs, or (b) located in a peripheral station (as describedin U.S. patent application 20070043585 by Matos), and referred to by acentrally located MP, by a centrally located administrator, or by anautomated call referral network. The MP may be the patient's physician,another physician, or a non-physician.

FIGS. 1B to 1F show a variety of system and device architecturesconstructed from an IMD, and control stations and state setting devices.FIG. 1B shows an IMD with 3 or more operating states, and externalcontrol station and a state setting device for setting the operatingstate of the IMD. The wavy two-way arrows indicate communication betweenthe devices linked by the arrows. FIG. 1C shows a system with an IMD, atleast one external control station and at least one state settingdevice. FIG. 1D shows an IMD with a local external station, and a remoteexternal station. FIG. 1E shows an IMD with three external controlstations. FIG. 1F shows an IMD with at least two external controlstations, with the three dots indicating the possibility of any numberof additional stations.

2.0 Hardware

FIG. 2 shows a patient device 200 communicating (a) wirelessly with anIMD 202 and (b) either (i) wirelessly or (ii) by a connection (brokenline) which may have both wired and wireless elements, with a remotestation 204. Transmitting and receiving device #1 206 in the IMDcommunicates with transmitting and receiving device (hereinafter “T/R”)#4 208 in the patient device, and T/R #3 210 in the patient devicecommunicates with T/R #2 212 in the remote station. T/R #2 and T/R #3may include apparatus to allow each of wired and wirelesscommunications. T/R #3 and T/R #4 are linked, so that the patient deviceas configured in FIG. 2 may also serve as a relay unit for conveyinginformation between the IMD and the remote station.

The input devices 214 and 216 allow for:

-   -   (a) the input of the unit by the patient with one or more of        text, voice, and video; for purposes of inputting patient        commands, patient requests for information and for patient        communication with the MP and the M.E. device;    -   (b) determining patient availability, if patient management of        the IMD is required;    -   (c) the patient to input the unit if a patient evaluation is        necessary in order to properly proceed with IMD management; and    -   (d) another person to input the unit, e.g. an arriving emergency        medical person or any other on-scene assisting person.        As shown in the figure, input device(s) A 214 is linked to T/R        #3 for communication with the remote station and input device(s)        B 216 is linked to T/R #4 for communication with the IMD;        patient device configurations in which one set of input devices        is linked to both T/R #3 and T/R #4 are possible as well. In        addition, the input devices are linked to the processors, memory        and control units 218 to allow for the aforementioned patient        control and patient evaluation functions.

One or more sensors 220, for detection of and inputting patient-relatedphysiologic information may be attached directly to the patient, or maybe in proximity to the patient without direct attachment. They input theprocessor, memory and control unit, and are the subject of FIG. 5 andthe associated specification.

The output device(s) 222 allow for the presentation of the patient withone or more of text, voice, and video; for purposes of:

-   -   (a) allowing the patient to obtain information from the IMD and        or the patient device itself, for purposes of management        decision making by the patient;    -   (b) patient communication with the MP;    -   (c) determining patient availability, if patient management of        the IMD is required;    -   (d) the patient obtaining management information from the M.E.        device;    -   (e) patient testing (cognitive or otherwise) during the process        of patient evaluation; and    -   (f) another on-scene person operating the unit.

The processor, memory and control unit:

-   -   (a) processes patient sensor information (see FIGS. 5, 17, and        19-2 1);    -   (b) performs and processes patient physiologic and cognitive        evaluations (discussed hereinbelow in conjunction with FIG. 18);    -   (c) may notify the patient of patient device-detected        physiologic conditions;    -   (d) may process information from the IMD concerning patient        events and may blend this information with patient sensor        information;    -   (e) processes patient commands (see FIG. 6);    -   (f) determines patient availability, if patient management of        the IMD is required (discussed in conjunction with FIGS.        29-56D);    -   (g) may participates in the selection of a control entity, and        may cause or process the enabling/disabling of patient access to        control of the IMD system (also discussed in conjunction with        FIGS. 29-56D);    -   (h) processes requests for patient sensor information;    -   (i) processes commands for sensor information processing    -   (j) controls patient device output displays;    -   (k) may process IMD power reserve information and use the        information for planning [i] communications with the IMD and        [ii] system management in general;    -   (l) controls each of T/R #3, T/R #4 and the patient device-based        output devices;    -   (m) stores software and firmware necessary to operate the        patient device system and associated patient sensors, stores        patient event related information, stores hierarchy/patient        access information (see FIGS. 14, 15 and 56B-56D); stores        passwords and/or access codes, stores encryption/decryption        information; and    -   (n) may perform other computational functions necessary to        maintain the patient device system.

FIGS. 3A-3D show four ways in which the patient device may link to asystem with an IMD, a remote station (“RS”) and one or more relay units.In FIG. 3A, a single item performs both (a) the management functionslisted hereinabove in conjunction with FIG. 2, and (b) the communicationrelay function, linking the IMD with the remote station. FIG. 3B shows aconfiguration in which a separate unit performs the relay function forcommunications among each of (a) the IMD, (b) the patient device, and(c) the remote station. FIG. 3C shows a system configuration in whichthe patient device communicates directly with the IMD, and in which theIMD communicates with the remote station via a separate relay device. Inthis configuration, the patient device may communicate with the remotestation through the IMD. FIG. 3D shows a system architecture similar tothat of FIG. 3C, except that the patient device communicates with theIMD through a separate communications relay device. Many otherarrangements of relay devices are possible, including configurations inwhich (a) one or more of the entities communicate through a series ofrelay devices and in which (b) one or more of the entities communicateover a route that changes from time to time. Other system architectureswhich accomplish the same goals—that is, robust communication among thepatient/patient device, the IMD and the remote station—will be obviousto those skilled in the art.

FIG. 4A shows a detailed block diagram of one configuration of theinvention, in which the (a) IMD 400, (b) the patient device 402 and (c)the remote station 404 are shown, as are relay units 406, 408, 410 whichfacilitate the communication among (a)-(c). The IMD device, showing ageneralized IMD system (similar to that of FIG. 1 of U.S. PatentApplication No. US/2008/0300659), includes a transmitter 412 andreceiver 414 for communication with each other unit in the IMD-system,sensors 416 for inputting physiologic information, a treatment device418, and processor, memory and control hardware 420.

The patient device in FIG. 4A shows a configuration with a singlereceiver 432 and transmitter 434. The patient device may communicate (a)directly with the IMD, (b) via one or more relay devices with the IMD,(c) directly with the remote station, (d) via one or more relay deviceswith the remote station. The IMD communicates with the remote stationthrough one or more relay units. In one embodiment of the invention, itmay also receive signals directly from the remote station.

Besides communications elements, the patient device also includes: thepatient input device(s) 422, patient output device(s) 424, theprocessor, memory and control unit 426, and sensor(s) 428 (Patientdevice sensors are further discussed in conjunction with FIG. 5,hereinbelow.), each as described hereinabove in conjunction with FIG. 2.FIG. 4A additionally shows apparatus in the patient device which allowsfor patient cognitive assessment. A patient assessment unit 430 causesone or more patient output devices 424 to present the patient with oneor more of (a) questions or other prompts intended to assess patientcognitive function and (b) any system messages, warning signals, andnotifications. The patient's response to each of these is inputted viaone or more patient input devices 422 and the response is assessed bythe assessment unit (see also FIGS. 9, 10, 18 and 19), and communicatedto the processor, memory and control unit 426.

The remote station 404 includes (a) medical expert device componentsincluding [i] a database 440 for storing information useful for managingthe IMD system, and [ii] a processor, memory and control unit 438 (seefurther discussion hereinbelow in conjunction with FIG. 12); (b) a T/Rdevice and/or wired connection 436 for communicating with one or more ofthe other entities in the IMD system; and (c) a link to the medicalprofessional which may involve a hardwired connection, a cableconnection, a wireless link or combinations of these.

FIG. 4B shows the exchange of signals within devices and among devices,comprising a system with an IMD 450, at least one external controlstation 470, and at least one external command station 476. Internalmedical data 462 is sensed by first sensor circuit 454, which amplifies,digitizes and optimizes the internal medical data in a manner known tothose skilled in the art. A sensor circuit output signal outputs viasensor circuit output 456, and goes to first processor 458. Thisprocessor generates internal control signal 460 in response to thesensor circuit output signal. The processor outputs a treatment devicesignal for controlling medical treatment device 452 in response to oneof (a) the internal control signal and/or (b) one of the receivedexternal control signals. The external control signal(s) and thehierarchy-setting signal are both received by 464,transmitting/receiving (T/R) device #1. This T/R device also transmitspatient information. Regarding element 464 and elsewhere hereinabove andhereinbelow, though identical names may be utilized for an informationcarrying signal before it enters and after it exits an electroniccircuit or device, it is to be understood that the amplitude,modulation, formatting, encoding and numerous other features of thesignal may change during such transit. For reasons of clarity, an “Xsignal” is intended to mean a signal representing X information, and isnot intended to specify the nature of the signal protocol, which willchange as the signal is transmitted and/or conveyed from one device orstructure to the next.

470 represents one or more external control stations, P in number. Eachof the P external stations has a T/R device 474 for communication withT/R #1 of the IMD. The external station receives patient information(signal representing internal medical data), and provides, ifappropriate, external control signals. A processor in each station 472,analyzes incoming information and generates, when appropriate, controlsignals.

476 represents one or more external command stations, Q in number. Eachof the Q external stations has a transmitting or T/R device 478 forcommunication with T/R #1 of the IMD. The command station provides, ifappropriate, hierarchy-setting signals for controlling the priority ofeach potential control signal for controlling the treatment device. Aprocessor in each command station generates, when appropriate, commandsignals.

FIG. 5 shows the relationship between a patient 500, the patient device502, sensors (which may be [a] implanted, [b] attached to the patient,and [c] in the vicinity of the patient) and other communicationapparatus which is in the vicinity of the patient. The patient isholding the communication device (see FIG. 6). A speaker 524 andmicrophone 526 may facilitate communications when the patient is in alocation that he/she frequents, e.g. the home or workplace;Alternatively these may be within the patient device or may be part of awearable earphone/microphone. The camera(s) 528 may be used (a) forcommunications with the MP, (b) to assess patient availability (i.e. toassume a management role [discussed extensively in conjunction withFIGS. 29-56B]), (c) to assess whether the patient has had a syncopalepisode (see FIGS. 10 and 21) and (d) to assist in the assessment ofpatient cognitive function.

The patient may continuously or intermittently be attached to one ormore devices for obtaining physiologic information including (a) a bloodpressure cuff 504 or other blood pressure sensing device, (b) a devicefor sensing one or more blood gases 506 (i.e. oxygen and/or carbondioxide), (c) two or more contact devices for sensing theelectrocardiogram, (d) a contact device for sensing respiratory motion(which may also be deduced from attached electrodes for sensing theelectrocardiogram), (e) a contact device for sensing skin resistance,[All contact devices have been indicated by a single element 508 in thefigure, without intending to imply that a single device performs all ofthe aforementioned sensing function.], (f) a contact device for sensingglucose (which may also be sensed by an implanted device) and (g) adevice for sensing the electroencephalogram 510.

The patient has at least one implanted device 512, which is the IMD ofthe system discussed herein. The patient may have one or more otherimplanted devices which either (a) augment the functioning of the IMDsystem (e.g. [i] one or more implanted sensors which communicate withthe system; [ii] one or more devices to facilitate communications withthe IMD), or (b) serve other therapeutic needs of the same patient; Forexample, the patient may have an ICD and an implanted drug infusionpump. In such a circumstance: (a) both devices may be remotelycontrollable, each through a separate IMD control system, (b) bothdevices may be remotely controllable, each through the same IMD controlsystem, (c) only one of the devices may be remotely controllable.

The patient's wearable device 514 may (a) serve as a communicationsrelay unit as described in U.S. Provisional Patent Application61/204,957, (b) be used for sensing either patient respiration and/or(c) be used for sensing patient attitude, motion or GPS coordinates.Acetone and other ketone compounds may be sensed by either a wearable orcontact device.

Though any of the aforementioned sensor devices may input the patientdevice through a hardwired connection or an infrared connection, in apreferred embodiment of the invention, the inputs will be via a shortrange wireless connection, likely radiofrequency. Signals from thesensor devices input the patient device receiver(s) 520, and via aninterface device 522 supply information to the patient device processor,memory and control unit 524. The 14 hexagonal shapes each indicate themovement of one type of sensor signal from the interface device to thepatient device processor, memory and control unit, including:

(a) information from implanted sensors;

(b) video information;

(c) audio information;

(d) ECG information;

(e) (lung) ventilation information;

(f) skin resistance;

(g) blood pressure;

(h) blood oxygen content;

(i) blood carbon dioxide content;

(j) blood sugar (glucose);

(k) electroencephalogram information;

(l) body attitude information;

(m) information from one or more accelerometers; and

(n) GPS information.

The further processing of the aforementioned information is furtherdiscussed in conjunction with FIGS. 9, 10 and others hereinabove andbelow.

FIG. 6 shows a representational view of a patient device 600. Among theitems which the patient may view on the screen 602 are:

(a) messages from any entity within the system including the IMD, thepatient device, the M.E. device or the MP;

(b) requests to select an IMD-system controller (see FIGS. 31, 36, 40,43, and 47);

(c) requests to take control of the IMD system (see FIGS. 29-43 and46-56B);

(d) programming choices and information which may be helpful inselecting among programming options;

(e) confirmation signals for commands sent by the patient;

(f) sensor information from the IMD;

(g) sensor information from the patient device (see FIGS. 8 and 9);

(h) patient interrogation questions and possible response choices;

(i) currently programmed hierarchical structure of the system (see FIGS.14 and 56B);

(j) currently programmed patient notification criteria (see FIGS. 53-56Band 71A-76C);

(k) programming choices made by entities other than the patient;

(l) patient device and IMD battery reserve information; and

(m) help menus, informational and instructional screens.

Patient input to the device may be via a touch sensitive screen (whichmay have virtual “buttons”), actual “buttons” which are switches, orboth.

Among possible patient controls (and shown in the figure) are:

(a) buttons which allow the patient (if given the option) to givecontrol to the MP, the M.E. device (previous two shown as one button buteither choice is possible), the patient device, the IMD or (if given theoption) himself/herself;

(b) a button which allows the patient to request control (see FIG. 53);

(c) buttons which allow the patient to contact the MP, the M.E. deviceor the patient's MD(s);

(d) a button which allows the programming of patient device sensormanagement; Touching this button may lead to display of screens such asare shown in FIGS. 17-21 [which may be screens for the professionalperson setting up the patient environment, and which the patient may belocked out of];

(e) a button which allows the programming of patient notification; Thismay also be something that the patient is locked out of and is handledby the MP or the patient's MD from a screen like that of FIG. 13; On theother hand, the patient may intermittently (or continuously) wish not toparticipate in IMD-system management, in which case he/she couldindicate this choice when appropriate;

(f) audio and video management;

(g) access to help and instructional information; and

(h) access to a variety of other programming options, communication andinformational options.

If the device in FIG. 6 is operative to also function as a conventionalcellular telephone, then, in addition to the screen and touch buttonfeatures discussed hereinabove, the device may also have screen andtouch button features that allow cellular telephone functionality.

FIG. 7A shows one feature of the invention, an IMD which may run morethan one treatment determining algorithm. The IMD in the figure has abasic structure similar to that of the IMD shown in FIG. 4A. Interfacedevices 702 and 704 between (i) the processor, memory and control unitand (ii) each of the transmitter 706 and the receiver 708, are forpurposes of encoding/decoding, encrypting/decrypting and any furthersignal processing needed to assure the compatibility of the unitsadjacent to the interface device. The receiver allows for the input ofpatient device sensor information, of patient cognitive information ofM.E. device information and of MP recommendations.

The IMD processor, memory and control unit 700 shown in FIG. 7 includesthree broken line rectangles labeled ALGO1 (element 710), ALGO2 (element712) and . . . ALGOn (element 714), intended to indicate the running oftwo or more different algorithms for the processing of patient dataleading to a treatment-related decision by the IMD. The algorithms may:

(a) be similar to those known in the art, (e.g. an ICD algorithm whichlooks at rate, rate stability, electrogram morphology, sudden onset,etc.);

(b) entail other transformations of IMD sensor information;

(c) blend the information from multiple IMD sensors;

(d) blend IMD sensor information with patient historical information;

(e) blend IMD sensor information with sensor information from thepatient device (including blending/considering patient cognitiveinformation);

(f) blend IMD sensor information with information from the M.E. device;

(g) blend an MP recommendation, if it is based on a not-total level ofcertainty about the diagnosis or optimum treatment;

(h) blend a patient recommendation with other information;

(i) entail neural network style learning features; and

(j) use combinations of (a)-(i).

The recommendations of each of algorithms 1, 2 . . . n may be a yes/nodecision, a numeric value indicating a treatment device setting, anumeric value indicating a level of certainty of a correct result, alist of options ranked according to preference, or a list of optionswith weighted rankings (e.g. an ICD algorithm which distributes 100points among treatment options and, for a given event recommends:

shock=81 points

anti-tachycardia pacing=17 points

continue observation=2 points).

The algorithm outputs are inputted into a master algorithm 716 whichprocesses the outputs of each of the individual treatment recommendingalgorithms 1, 2 . . . n (See details of such processing in FIGS. 57 and58 and the associated specification.). The value of a list of options(whether ranked or weighted), if available, is that it may facilitatethe master algorithm's reaching a consensus among non-identicalrecommendations from the individual contributing algorithms 1, 2 . . .n.

With the availability of new management information at a later time, theMP or system administrator may choose to update/modify any one or moreof algorithms 1, 2 . . . n, or the master algorithm, which may be doneif/when access is permitted, via the IMD receiver.

The algorithms may run on the same processor or different processors.They may run serially or in parallel. Numerous variations in theirformat will be obvious to those skilled in the art.

IMDs which employ only a single treatment algorithm are possible, andare compatible with every other aspect of the inventions describedherein.

FIG. 7B shows an arrangement with multiple sources of control signalsinputting into a master IMD algorithm 742. These include the treatmentchoice of the device internal algorithm 744 (this treatment choicereflected by the internal control signal 460 of FIG. 4B) based oninformation coming from device sensors among other things, a medicalprofessional control signal 734, a patient control signal 738, andcontrol signals from a medical expert device 736 and a patient device740. These latter four signals are received by IMD receiver 730, andprocessed by interface device 732.

FIGS. 8-11 show block diagrams of each of the IMD and patient devicetransmitters and receivers, with a hexagonal box indicating each of thesignal types that may be trafficked.

FIG. 8 shows signals transmitted by the IMD. Except for unprocessedsensor data coming from the IMD sensors 800, each other type of signalcomes from the IMD processor(s), memory and control unit 802. Thesignals include:

(a) information indicating the results of the analysis of the IMDtreatment algorithm, and if there is more than one such algorithm,information indicating the analysis of each such algorithm. Thisinformation may be useful to the MP for decision making. It may also beuseful to the patient and/or the patient device, which may have accessto additional information to blend with the IMD algorithm analysis.Alternatively, relevant patient and/or patient device information may besent to the IMD (see FIG. 10) and blended, at the IMD, with the IMDalgorithm outputs. The algorithm outputs may also be sent to the M.E.device for archiving, and future analysis, and for use in theformulation of M.E. device treatment instructions or recommendations;

(b) in the case of an IMD which runs multiple treatment algorithms asdescribed in FIG. 7: information indicating the results of the blendingof these multiple recommendations by the master algorithm (as discussedin conjunction with FIG. 7);

(c) in a case where the patient device has sent (to the IMD) sensorinformation with either physiologic information, cognitive informationor both: the results of a combined analysis of that information with theIMD sensor information;

(d) confirmation signals indicating:

-   -   (i) that a programming change has been properly executed;    -   (ii) that a treatment instruction has been properly executed;

(e) power reserve information related to one or more IMD batteries;

(f) requests to the patient, the patient device or the M.E. device formore information for decision making purposes; and

(g) notification signals for one or more of:

-   -   (i) the patient.    -   (ii) the MP,    -   (iii) the patient device, and    -   (iv) the M.E. device.

Each of the aforementioned signal types is passed to the IMD transmitter804 via the interface device 806. The latter device has propertiessimilar to those of the interface devices described in conjunction withFIG. 7, hereinabove.

FIG. 9 shows the signal types coming into the patient device receiver900. The interface unit 902 functions as described in FIGS. 7 and 8. Theincoming signals include each of the types of signals discussed inconjunction with the signals outputted by the IMD transmitter (exceptfor signals obviously targeted for other system entities [e.g. “MPNotification” ]). In addition, the incoming signals include:

(a) patient sensor information (see FIG. 5);

(b) incoming communication signals during patient-MP exchanges;

(c) requests for assessment of patient alertness or other parameters ofthe patient cognitive state (as a reflection of [i] the patient'scardiac output, [ii] the patient's metabolic state, and/or [iii] thepatient's neurologic condition);

(d) patient warning signals—e.g. of a system or device fault, acommunications fault or weakness, or of a patient medical problem ofwhich the patient may be unaware (and which does not require IMD therapyput is detectable by the system). As discussed in conjunction with FIG.4A, the patient acknowledgment of and/or response to such warningsignals may also serve as part of the patient cognitive evaluation;

(e) management selection signals, i.e. (i) signals which indicate thatthe patient or the patient device is requested to choose which of anumber of IMD system entities will be the dominant/managing entity; (ii)signals which indicate that the patient or patient device has beenselected to be the dominant/managing entity (see FIGS. 29-43 and 46-52),or (iii) signals requesting information about patient availability foreither (i) or (ii) herein;

(f) programming commands for patient device sensors (see control screenFIGS. 17, 19-21);

(g) programming updates related to the status in the control hierarchyof either the patient, the patient device or both (see screen FIGS. 14and 15, and algorithm flow diagram FIG. 56B); and

(h) miscellaneous control or information request signals from any of thesystem entities.

Each of these incoming signals is conveyed to the appropriate one of (i)the patient device processor, memory and control unit 904, (ii) thepatient assessment unit 906, or (iii) the patient output devices 908, asindicated in the figure.

FIG. 10 shows signals which may be transmitted by the patient device:

(a) signals indicating a patient state of consciousness; Such signalsmay assign one of three classifications (fully conscious, unconscious orintermediate) as shown in the figure, may use a simpler system(conscious or unconscious), or a more complex system (e.g. indicating anumeric rating of the patient assessment unit);

(b) signals indicating the probability that a patient has fallen; Suchsignals may assign one of three classifications (possible, probable ordefinite) as shown in the figure; may use a simpler system (fall or nofall), or a more complex system (e.g. indicating a numeric rating of theprobability of a fall); These signals may be derived from the analysisof information from sensing devices in the patient environment (see FIG.5):

-   -   [i] information from one or more cameras;    -   [ii] information from one or more attitude indicators which may        be worn by (or implanted in) the patient;    -   [iii] information from one or more devices which may sense a        sudden deceleration which may be indicative of a fall, e.g.        accelerometers; and/or    -   [iv] one or more microphones which may pick up the sounds        associated with a patient fall;

(c) signals which provide patient physiologic information (see FIG. 5)such as:

-   -   [i] ECG information;    -   [ii] information about the patient's respiration;    -   [iii] information about the patient's hemodynamic function; and    -   [iv] other patient physiologic information;

(d) other information including:

-   -   [i] response to requests concerning patient availability to        participate in clinical management decisions;    -   [ii] response to requests for the patient to select an entity in        the IMD system for clinical management decisions;

(e) commands and suggestions for the IMD

-   -   [i] from the patient, if the patient has been granted such        access;    -   [ii] from the patient device, if the patient device has been        granted such access; and

(f) outgoing communication signals during patient-MP exchanges.

FIG. 11 shows signals which may be received by the IMD:

(a) signals transmitted by the patient device indicating the patient'sstate of consciousness;

(b) signals transmitted by the patient device indicating the probabilitythat the patient has fallen;

(c) signals conveying physiologic information from the patient device;

(d) signals from any entity in the IMD system which either

-   -   [i] control the IMD treatment device (by either a control signal        which results in real time treatment, or by a control signal        which reprograms the IMD),    -   [ii] cause the IMD to control its own treatment device, or    -   [iii] cause the IMD to select a control agent from among the        allowed entities in the system;

(e) signals from the patient device or M.E. device (or the patient orthe MP) which request the transmission of IMD information;

(f) signals which cause the programming or reprogramming of thecriteria/conditions for which the IMD notifies one or more of the otherIMD system entities; and

(g) signals which result in the programming or reprogramming of the IMDstatus in the control hierarchy (see screen FIGS. 14 and 15, andalgorithm flow diagram FIG. 56B).

FIG. 12 is a block diagram of one configuration of a medical expertdevice. The device stores information about patient events and providesautomated expert advice.

The M.E. device operates in three modes.

In the first mode, it categorizes and stores information about clinicalevents including both (a) descriptors of the event and associatedclinical information; and (b) sensor information from [i] implanteddevice(s) and sensors, and [ii] external sensors, if any, therebycreating a library of such events.

In an optional second mode, the M.E. device analyzes the sensorinformation and the associated clinical information, searching forrelationships among which associate sensor signals, clinical variables,treatment state and outcomes.

In a third operating mode, the device responds to requests for treatmentadvice or instructions; It provides this based on previously storedalgorithms which may be supplemented by information in the eventlibrary, which is either (a) digested/processed, or (b) simply a matchor near match for the current patient state.

As shown in the figure, information about a clinical event enters theM.E. device either via a wireless or wired connection 1200. Theinterface device 1202 for incoming signals functions as indicatedhereinabove.

In the first operating mode, incoming sensor information (supplied byparticipating patients and/or MDs) may include minimally processed orunprocessed sensor signals (e.g. electrograms, signals from implantedbrain electrodes) or processed signals (e.g. information about sequencesof V-V intervals). Clinical data may include:

(a) patient identification information;(b) time and date of the event;(c) the patient's implanted device model and serial number;(d) information about associated implanted hardware (e.g. a lead modeland serial number in the case of an ICD);(e) information about the external patient device;(f) the patient medications, and compliance with the regimen, if known,for the day or days preceding the event;(g) additional information about the patient's medical history, bothrecent and remote;(h) any unusual events that may have been going on at the time of theevent, either medical or other;(i) the identity of the patient's physician, and this physician'spreferences, if known, about treatment of similar events;(j) information about any similar events which this patient may haveexperienced in the past; and(k) the results of treatment, if the data was collected at or around thetime that the IMD was administering such treatment.

The set of sensor and clinical information is then assembled, labeledand stored in the event library 1204, so that it may be referenced byany one or more of search labels (a) through (k) and or by descriptorsof the sensor signals.

In the second operating mode, the processor, memory and control unit1206 may analyze information in the event library looking for patternswhich either predict successful treatment outcomes, or patterns whichpredict serious or catastrophic events.

In the third operating mode, an incoming request for treatmentinformation results in:

(a) standard treatment, if a previously developed algorithm has a highprobability of a desirable outcome,

(b) a search of the medical library for comparable sensor signals,clinical data or some of each (from this patient and/or other patients),and uses this information to form the basis of a treatmentrecommendation; or

(c) a combination of (a) and (b) herein, in which the medical librarysearch results in the modification of an algorithm, or the selection ofone of a number of optional branches of an algorithm, for treatmentmanagement.

The treatment instructions developed in this way are outputted (via theinterface device 1208 with aforementioned function) from a wired orwireless connection 1210.

In the case of an ICD, sets consisting of both (a) electrograms orinformation about details of the heart rhythm and (b) clinical data, arelabeled and stored in the M.E. device event library, as indicatedhereinabove, for a variety of patient conditions, e.g. rest, exercise,tachycardia. Many such electrogram/clinical data sets, from manypatients are stored in the event library, over a span of time. Thetrigger for storage of information in the event library may be (a) anevent which required ICD therapy, (b) the retrieval of information aboutsuch treatment events at the time of a visit to the MD's office, (c) avoluntary patient transmission, and/or (d) a random sampling. Later, anentity in an ICD system (e.g. the ICD or the MP) may seek M.E. deviceguidance for the management of a particular episode of tachycardia. Arequest to the M.E. device for treatment instructions may triggers asearch for:

(a) a similar electrogram, at a similar heart rate which was previouslysuccessfully treated, having occurred in the patient currentlyexperiencing the tachycardia;

(b) a similar electrogram, at a similar heart rate which wassuccessfully treated in another patient or group of patients; and/or

(c) somewhat similar electrograms, in a plurality of previouslysuccessfully treated patients with very similar clinical data, comparedto the current patient. If the search can be completed in an interval oftime which would be acceptable, and if useful archival information isidentified during that interval, then the referenced information about aprior successful treatment may be used to guide the currentrecommendation. If the search is not completed in an acceptable time, orif no match for the current condition and a successful treatment isfound, then a stock treatment algorithm is employed by the M.E. device,or the M.E. device instructs the ICD to proceed with preprogrammedtherapy.

The event library will be useful for any clinical situation where simplealgorithmic management of highly complex sensor output information isinadequate or suboptimal for making complex treatment decisions. Suchsituations may occur with ICDs, with the analysis of brain signals totreat brain abnormalities including seizures and other neurologicdisorders, with the management of blood sugar by an implantable insulinpump, and with other IMDs.

The M.E. device may be used in an IMD system with or without a patientdevice.

3.0 Management Screens

FIGS. 13-21 show nine computer screens each of which allows a personaccess to the various aspects of IMD system control. The person usingthese screens would likely be the MP, and might be a specially selectedMP with skills to use these screens. Alternatively, one or more of thescreens might be accessed by the patient's physician or by the physicianwho implants the IMD (e.g. FIG. 16). Still other screens might beaccessed by a technical person setting up the patient device or theenvironment in which the patient device operates (e.g. FIGS. 20 and 21).The screens contain rectangular entities intended to indicate (a)touch-sensitive virtual “buttons” for indicating a user preference, and(b) display areas within a screen. Configurations of the system withactual buttons are possible; Configurations of the system with more thanone simultaneously viewable screen are possible; Many suchconfigurations will be evident to those skilled in the art.

FIG. 13 shows a control screen 1300, which allows the MP a wide range ofprogramming and control options including:

(a) giving the control of IMD function (e.g. for a fixed duration oftime, or indefinitely, until reprogrammed again) to any of the possiblecontrol agents of the system (as shown in the algorithms, for example,of FIGS. 33, 38 and 52):

-   -   [i] himself/herself;    -   [ii] the M.E. device;    -   [iii] the patient:    -   [iv] the patient device; or    -   [v] the IMD.        In the screen configuration shown in the figure, the MP has the        capability of giving control to any of three IMD algorithms.        Embodiments of the invention with more or fewer IMD control        algorithms are possible. In a preferred embodiment, would give        control to the IMD in general, and if that IMD had multiple        parallel internal IMD control algorithms, the MP would allow an        IMD master algorithm (see FIG. 7) to automatically select        therapy.

If the MP takes control of the IMD, then one or more of the threescreens in the upper section of the figure will show one or more menusallowing the MP to exercise direct IMD control.

(b) request control of the IMD; This is a feature of the algorithm shownin FIG. 53, in which the MP and the patient may “negotiate” which if thetwo is to be the control agent;

(c) the programming or reprogramming of control hierarchy (see FIGS. 14,15 and 56B), i.e. which of the IMD system entities has priority overwhich other entities; Touching this button will lead to the screen shownin FIG. 14;

(d) programming or reprogramming of access to control hierarchy i.e. theselection of which particular individuals are allowed to program controlhierarchy; Touching this button will lead to the screen shown in FIG.15;

(e) program or reprogram notification criteria (see, for example, FIGS.71A-76C) or second notification criteria (see, for example, FIG. 23) ateither the IMD, the patient device or the M.E. device;

(f) for each of the IMD, the patient device or the M.E. device, toprogram or reprogram one or more of criteria for:

-   -   [i] takeover,    -   [ii] return of control,    -   [iii] second takeover, and    -   [iv] second return of control, (see algorithms in FIGS. 59-70);

(g) program or reprogram other features of other devices in the IMDsystem, via the buttons labeled:

-   -   [i] IMD;    -   [ii] patient device; and    -   [iii] M.E. device; and

(h) control IMD system communication features, by touching “GO TOCOMMUNICATIONS CONTROL SCREEN”, which leads to a menu driven tree ofchoices appearing within one or more of the screens as is shown at thetop of the figure.

The IMD may choose to contact the patient for a variety of reasons (todiscuss device programming, to discuss the management of an actualevent, to directly evaluate the patient, to discuss a potential oractual malfunction, etc.), and can do so (via the patient device, or byother means) by touching “CONTACT PATIENT.”

The MP is given access to a variety of information to facilitate his/herdecision making:

(a) data from IMD and/or patient device sensors;

(b) IMD analysis of [i] IMD sensor information and/or [ii] patientdevice sensor information;

(c) the therapy selections of one or more other entities in the system;

(d) text messages from the patient, the patient device, the M.E. deviceor the IMD;

(e) archived information concerning the patient history (or additionalinformation from the M.E. device library); and

(f) GPS information, if a GPS device is part of either the IMD or thepatient device.

FIG. 14 shows a control screen 1400, which allows the screen user todetermine control hierarchy in an IMD system (to be used in conjunctionwith a control algorithm similar to that shown in FIG. 56B). The usermay select a hierarchy which pertains to all medical conditions, or mayselect one such hierarchy for a first set of medical conditions (labeledA1, A2, A3), a different hierarchy for a second set of medicalconditions (labeled B1, B2, B3, B4), etc. The specific medicalconditions are specified by touching the button(s) labeled “TOUCH TOSPECIFY CONDITIONS . . . ” after which specific conditions (e.g. for anICD, a range of heart rates) are entered. The hierarchy is programmedby:

(a) for each set of conditions, touching the button in the primarycontroller column which will lead to a menu showing each of the entitiesin the IMD system; One of these is selected;

(b) then, if there is to be a secondary controller, touching the buttonin the secondary controller column which will lead to a menu showingeach of the remaining entities (i.e. other than the already selectedprimary controller) in the IMD system; One of these is selected;

(c) then, if there is to be tertiary and higher order controllers,touching the buttons in the corresponding controller columns, which willeach lead to a menu showing each of the remaining entities (other thanthe already selected ones) in the IMD system; These are selected asrequired.

In the figure, an example is shown in which:

(a) for conditions A1-A3, the IMD is the primary controller, and theMP—as the secondary controller—may overrule the IMD;

(b) for conditions B1-B4, the IMD is the primary controller, thepatient—as the secondary controller—may overrule the IMD, and the MP—asthe teritary controller—may overrule each of the patient and the IMD;

(c) for conditions C1, the IMD is the primary controller, the patient isthe secondary controller, the patient device is the tertiary or thirdlevel controller, the M.E. device is the fourth level controller, andthe MP is the highest level controller; In the nomenclature selected,each entity may overrule each other lower level entity;

(d) for conditions D1-D3, the patient is the primary controller, thepatient device or the IMD is the secondary controller [intended toindicate that either example is possible], and the MP is the tertiarycontroller; and

(e) for conditions E1 and E2, only the MP may control the IMD.

FIG. 54 hereinbelow shows an algorithm which would be affected if theselections in the second row of FIG. 14 were made. The specification inconjunction with FIG. 54 includes two examples of IMD systems that mightfunction accordingly. One of the control scenarios addressed by U.S.Pat. No. 7,277,752 (Section 8.6 and FIG. 60) parallels that which wouldbe affected if the selections in the first row of FIG. 14 were made. Analgorithm similar to that shown in FIG. 56A herein would be affected ifthe selections in the third row of FIG. 14 were made (though that inFIG. 56A has the patient as the tertiary controller and the patientdevice as the secondary controller).

The specification in conjunction with FIG. 56B discusses having a singleIMD programmed so that it operates with different control hierarchiesfor different medical conditions. For example, an ICD could beprogrammed:

for relatively slow tachycardias (e.g. rate 140 to 160 b.p.m.), tooperate with the hierarchy indicated in row 2 of FIG. 14, in which theIMD is the primary controller, the patient may overrule the IMD and theMP may overrule either the patient or the IMD;

for most other tachycardias (e.g. rate 160 to 460 b.p.m), to operatewith the hierarchy indicated in row 1 of the figure, in which the IMD isprimary, the MP may overrule, and the patient does not have controlaccess; and

for a specific set of conditions in which there is a very highlikelihood that sensor signals are being generated by a malfunctioninglead (e.g. repetitive short bursts of very high rate signals [with orwithout additional evidence from the patient device that these signalsdo not correspond to true cardiac rhythm abnormalities]), to operatewith the hierarchy indicated in row 5 of the figure, in which only theMP has access to control.

The MP or other person using the control screen shown in FIG. 14 mayprogram any of the devices in the IMD system by making his/her hierarchyselections and then touching the corresponding button from among thosethree in the bottom row of the screen.

FIG. 15 shows a control screen 1500, for programming the access to thecontrol screen for control hierarchy shown in FIG. 14. Since controlhierarchy is at the core of system functioning, and since its properprogramming may depend on the ability of one individual (e.g. the MP) toassess the competence of other individuals (e.g. the patient, or thepatient's physician), in a preferred embodiment of the inventions, amechanism should be in place to establish and maintain the control ofcontrol hierarchy. An example of such an approach is the touch sensitivescreen shown in FIG. 15.

The user is instructed to select one choice in each of the first threerows. Row 1 is set up at the time of initial system setup, and is usedto determine whether, in the future, an MP may access the systemautonomously, or whether the MP will requires additional permission,i.e. from the patient's physician, or from a specifically designatedphysician. MP access could be further restricted to only certain MPs,and the passwords of those MPs who are allowed system access may beentered by touching the “ENTER MP PASSWORD” button, and entering theappropriate passwords using either an actual keyboard or a touchsensitive screen.

By touching one of the buttons in row 2, the individual performing thesetup determines which physician(s), if any will have access to theprogramming of control hierarchy. The setup individual may restrictaccess to specific MDs (and enter their passwords by touching the “ENTERMD PASSWORD BUTTON”), or restrict access to MDs who have MP permissionat the time. Alternatively, the setup individual may decide to deny MDaccess in general. (Such a decision would not be irreversible, since, ata future time, a MP with access to the control screen shown in FIG. 15could alter the decision.)

Whether the patient may have access to control hierarchy programming isdetermined when one of the buttons in row 3 is touched. The choices, inthe embodiment of the invention shown in the figure, are (a) the patientwho has the patient device (without restriction except for the need forpassword entry), (b) the patient, with MP permission at the time ofprogramming, (c) the patient, with physician permission at the time ofprogramming, and (d) no patient access allowed. If the patient isallowed access, the setup person enters their password by touching the“ENTER PT PASSWORD” button.

FIGS. 16 and 17 show an example of control screens for programming anICD which allow for the use of information about the patient obtained atthe patient device to either accelerate or decelerate the typicallyescalating aggression of ICD therapy for an episode of tachycardia.

Referring to FIG. 16, within control screen 1600, each of the fourcolumns of rectangular buttons program one “tier” of ICD therapy, withincreasing aggressiveness of therapy from the left-most to the rightmost column, as is known in the art. Shown in the figure are:

(a) a least aggressive tier of therapy which consists of gentleantitachycardia pacing (“ATP”);

(b) a more aggressive tier of therapy which consists of more aggressiveATP (e.g. shorter pacing cycle lengths, more rapidly escalating pacingrate from one pacing attempt to the next, etc.);

(c) a still more aggressive tier of therapy which consists of a lowenergy shock;

(d) an even more aggressive tier of therapy which consists of highenergy shock. Typically, additional high energy shocks would beprogrammed to occur following the fourth tier.

In the ATP tiers, categories of choices are shown which allow for theselection of details of the ATP such as the pacing rate, the number ofpaced beats and the number of pacing attempts, etc.—typical of presentday ATP programming. Each touch button leads to a menu of options (e.g.number of beats could be selected from 3, 4, 5, 6 . . . ). Similarly,submenus may be accessed for the selection of shock-related parameterssuch as shock energy, polarity, waveform, electrode choice, etc., eachleading to a menu of choices. Numerous variations of therapy, offormatting ICD therapy menus, and of selecting from among the choices onthe menus are known and used on an everyday basis.

The lower five rows of buttons in the figure show how information aboutthe patient's condition obtained at the patient device may be used tomodulate the aforementioned escalating therapy.

If the patient device indicates that the patient condition is poor, thenthe ICD may be programmed to skip a tier of therapy. Furthermore, if thepatient's condition, as assessed by the patient device, worsens while atier is in progress, the ICD may be programmed to terminate that therapytier and move to the next one upon such detection.

If the patient device indicates that the patient condition is good, thenthe ICD may be programmed (i) to repeat a tier of therapy one or moretimes, or (ii) to not advance beyond a particular tier of therapy.Furthermore, if the patient indicates that their condition is good, thensuch an indication may be allowed to cause a repeat or a non-advancementof therapy.

There are numerous ways in which patient condition may be assessed, andthe control screen 1700 shown in FIG. 17 illustrates one approach:Overall patient condition is semi-quantitatively assessed by assigningit an integer value between the number 1 and the number 10, where 10indicates the best condition, and 1 indicates the worst condition. Thedefinition of each of the ten states so delineated may be either (a)explicitly programmed by using the screens in FIGS. 18-20, or (b)selected by an “autoblend” feature, in which a predetermined method ofweighting of one or more sensor input values, and of blending the valuesif there are two or more, is used to determine the integer correspondingto the patient state, on the 10 integer scale.

For example, using a single sensor, one possible set of default valuesfor a respiratory assessment would be:

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Contents andAssociated Figures: 1.0 System Overview FIGS. 1A-1F 2.0 Hardware FIGS.2-12 3.0 Management Control Screens FIGS. 13-21 4.0 Triaging UsingFunction* FIGS. 22A-24 5.0 Patient Assessment Algorithms FIGS. 25-26 6.0System Architecture Summary FIGS. 27A-27C 7.0 System ManagementAlgorithms, overview FIG. 28 7.1 3-Entity Systems with IMD, Patient AndMedical Professional FIGS. 29-37 7.2 3-Entity Systems with IMD, Patientand Patient Device FIGS. 38-43 7.3 Generalized 3-Entity Systems FIGS.44-45 7.4 2-Entity Systems with IMD and Patient FIGS. 46-49 7.5 5-EntitySystems with IMD, Patient Device, Patient, Medical Expert Device AndMedical Professional FIGS. 50-52 7.6 Alternate 3-Entity System with IMD,Patient and Medical Professional FIG. 53 7.7 Second Alternate 3-EntitySystem with IMD, Patient and Medical Professional FIGS. 54-55 7.8Alternate > or =5-Entity Systems with IMD, Patient Device, Patient,Medical Expert Device and Medical Professional FIGS. 56A-56D 7.9Blending of Two or More Analysis or FIGS. 57-58 Control Algorithms 7.10Control Handoff Algorithms 7.10.1 Takeover and Return of Control FIGS.59-62 7.10.2 Takeover #2 FIGS. 63-65 7.10.3 Return of Control #2 FIGS.66-67 7.10.4 Time Dependent Formats FIGS. 68-70 8.0 Use of Function* forTriage 8.1 2 Zone Formats FIGS. 71-73 8.2 3 Zone Formats FIGS. 74-76 9.0Clinical Examples, overview FIG. 77 9.1 Blood Sugar Management FIG. 789.2 Ventricular Tachycardia Management FIGS. 79-82Other tables of values or curves representative of such tables could beentered via the screen shown in FIG. 20 (see below).

A possible set of default values for blood pressure assessment would be:

TABLE B Systolic Blood Pressure Patient Assessment (mm · Hg) 10 >100 9 95-100 8 90-95 7 85-90 6 80-85 5 75-80 4 70-75 3 65-70 2 60-65 1  <60

In an example using two sensors, one for respiratory rate and one forblood pressure, a possible set of default values for a respiratoryassessment would be:

TABLE C Blended Assessment RESPIRATORY SCORE: of BP Score and 8-10 6-74-5 1-3 Respiratory Score BP Score BP Score BP Score BP Score 10 10 9 98 8 10 7 7 9 6 6 8 10 5 5 7 9 4 4 6 8 10 3 3 5 7 9 2 2 3-4 5-6 6-8 1 11-2 1-4 1-5

Patient assessment, besides the use of standard physiologic parametersmay also involve a brief neurophysiologic assessment. The assessment maybe quick, involving the patient response to one or a few questions (viathe patient device), and may be valuable for assessing hemodynamicconsequences that are not fully reflected by blood pressure, or forassessing metabolic or neurologic states. An example of a setup screenfor such an assessment is shown in FIG. 18, and is discussed below. Inthe example shown, the output of the assessment is a cognitive rating ofeither “good”, “fair”, or poor. Many other rating scales will beapparent to those skilled in the art.

Below is a table in which one physiologic parameter and the results of acognitive evaluation are combined to generate a single integer valued 1through 10, reflecting the patient overall state:

TABLE D Blended Assessment of Respiratory COGNITIVE SCORE: Score andPatient GOOD FAIR POOR Interrogation Resp. Score Resp. Score Resp. Score10 10  9 9 8 8 7 7 10  6 5-6 9 5 3-4 8 4 2 6-7 3 1 4-5  8-10 2 2-3 6-7 11 1-5

Referring again to Table 16, the person programming the screen in FIG.16 may elect to skip Tier 1 therapy if the semi-quantitative assessmentof patient condition, based on the patient's respiratory status only, isless than or equal to 5 on the aforementioned scale of 10. (See Table A,above.) This would be programmed by:

-   -   (i) touching the “SKIP TIER IF” box in column 1 of the screen in        FIG. 16, which would lead to the screen in FIG. 17;    -   (ii) then touching “5/10” in the “THERAPY PROGRESSION        ACCELERATOR” section of the screen shown in FIG. 17, and    -   (iii) then touching “WITHOUT PATIENT INTERROGATION.”        If there are additional physiologic sensors besides respiratory        rate, then the screen shown in FIG. 19 would be used to        specifically select respiratory rate (see below).

If desired, the programming person could then return to the screen inFIG. 16 by touching either “GO TO MAIN THERAPY SCREEN” or “GO TOPREVIOUS THERAPY SCREEN,” to perform additional programming. Referringagain to column 1 of the figure, the “TERMINATE TIER IF” would be set upin a manner similar to the “SKIP TIER IF,” procedure discussedhereinabove.

The programming person may wish to program “therapy progressiondecelerators,” i.e. physiologic standards which, if met, result inadditional time spent with the delivery of non-aggressive therapy,resulting in the deferral, or possibly the prevention of more aggressivetherapy. For example, the person programming the screen in FIG. 16 mayelect to repeat Tier 1 therapy if the semi-quantitative assessment ofpatient condition, based on the patient's respiratory and cognitivestatus, is greater than or equal to 8 on the aforementioned scale of 10.(See Table D, above.) This would be programmed by:

-   -   (i) touching the “REPEAT TIER IF” box in column 1 of the screen        in FIG. 16, which would lead to the screen in FIG. 17;    -   (ii) then touching “8/10” in the “THERAPY PROGRESSION        DECELERATOR” section of the screen shown in FIG. 17, and    -   (iii) then touching “WITH PATIENT INTERROGATION.”        As indicated above, the screen in FIG. 19 may need to be        additionally accessed.

If desired, the programming person could then return to the screen inFIG. 16 (as described above) to perform additional programming.Referring again to column 1 of the figure, the “DO NOT ADVANCE BEYONDTIER IF” could be set up in a manner similar to the “REPEAT TIER IF,”procedure discussed hereinabove, except that a value of “9/10” might beselected for this therapeutic approach.

The programming person may find it advantageous to allow for directpatient input at the time of a rhythm abnormality. The input could be atherapy decelerator or accelerator, and the specific amount of latitudethat the patient could have would be pre-specified. For example, it maybe desirable to prevent the advancement beyond Tier 1 if both (a) thepatient overall assessment is “10/10” and (b) the patient, based onhis/her own sense that he/she is tolerating the tachycardia well, wouldlike to defer higher tiers of therapy. To program this condition (withpatient interrogation), the programming person:

-   -   (i) touches the “ALLOW PATIENT INPUT IF” box in column 1 of the        screen in FIG. 16, which would lead to screen 1700;    -   (ii) then touches “10/10” in the “THERAPY PROGRESSION        DECELERATOR” section of screen 1700, and    -   (iii) then touching “WITH PATIENT INTERROGATION.”        Examples with therapy acceleration will be possible, using the        “THERAPY PROGRESSION ACCELERATOR” portion of the screen shown in        FIG. 17, in conjunction with the “ALLOW PATIENT INPUT IF”        button.

Referring again to the screen 1600, the programming of therapyaccelerators and decelerators for Tier 2 (column two of the figure),proceeds along the same conceptual and methodologic lines as for theTier 1 programming described hereinabove. “ALLOW PATIENT INPUT” has beenomitted, based on the lesser degree of appropriateness for patient inputto a more aggressive therapy. For example, the person programming thescreen in FIG. 16 may elect to repeat Tier 2 therapy if thesemi-quantitative assessment of patient condition, based on thepatient's blood pressure and respiratory, is greater than or equal to 8on the aforementioned scale of 10. (See Table C, above. It wouldinclude: [i] states with both of (1) respiratory score 8-10 and (2)blood pressure score 8-10; and [ii] states with both (1) respiratoryscore 6-7 and (2) blood pressure score 10.) This would be programmed by:

-   -   (i) touching the “REPEAT TIER IF” box in column 2 of screen        1600, which would lead to screen 1700;    -   (ii) then touching “8/10” in the “THERAPY PROGRESSION        DECELERATOR” section of the screen 1700, and    -   (iii) then touching “WITH PATIENT INTERROGATION.”

If there are additional physiologic sensors besides respiratory rate andblood pressure, then the screen shown in FIG. 19 would be used tospecifically select these two choices (see below).

Referring again to screen 1600, the programming of therapy acceleratorsfor Tier 3 (column three of the figure), proceeds along the sameconceptual and methodologic lines as for Tier 1 and 2 programmingdescribed hereinabove. Therapy decelerators have been omitted.

Embodiments of the invention with numerous variations in theabove-discussed programming features are possible (e.g. allowing morepatient access, allowing no patient access, allowing greater or feweropportunities for therapy acceleration or deceleration based onpre-programmed algorithms which use patient assessment, etc.).

There are four additional navigation buttons at the bottom of screen1700:

(a) “GO TO PATIENT INTERROGATION SCREEN” leads to the screen shown inFIG. 18, allowing detailed programming of patient cognitive assessment;

(b) “GO TO MASTER BLEND SCREEN” leads to the screen 1900 in FIG. 19,allowing the programming of the details of sensor blending;

(c) “GO TO SYNCOPE SENSOR BLEND SCREEN” leads to screen 2100 shown inFIG. 21, allowing the blending and individual adjustment of sensorswhich allow the assessment of whether the patient has fallen and/or hada syncopal episode; and

(d) “GO TO PHYSIOLOGIC SENSOR BLEND SCREEN” leads to screen 2000 shownin FIG. 20, allowing the blending and individual adjustment ofphysiologic sensors associated with the patient device.

Patient interrogation allows for a performance assessment of thefunctioning of the patient's brain, which generates additionalinformation on which to base therapy decisions. The interrogationinformation may supplement the assessment of cardiac performance, ofmetabolic state, and of neurologic state. The setup screen shown in FIG.18 is one of many possible screens that perform this function.

As indicated in the discussion of FIG. 4A, the patient evaluationprocess may consist of at least one of (a) assessing whether the patientresponse to system prompts and warning signals is timely and/orappropriate, and (b) assessing the response and timing of the responseto test questions posed to the patient. Although such responses can notbe instantaneous, important information can become available in afraction of a minute, which in some circumstances may be available fordecision making. The patient (a) may be presented with an audio format,(b) may be shown a text version of the questions on the screen for thepatient device shown in FIG. 6, or (c) may be presented with a textversion following an alerting audio announcement or tone. The patientanswers may be via a touch sensitive screen on the patient device, orspoken words.

Using the buttons shown for the top/first line of 1800, the controlscreen shown in FIG. 18, the programming person may choose one or moretypes of test questions, to be posed to the patient when necessary. Thecategories shown on the screen are (a) calculations (e.g. simple mentalarithmetic), (b) short term memory (remember the names of three objectsafter a given time interval, e.g. 20 or 30 seconds), (c) politiciannames (“Who is the Governor?”) and (d) solving a visual puzzle (e.g. amaze or an exercise that requires inverting a rotating a visual image).Touching each of the virtual buttons corresponding to these categories:(a) may lead to the inclusion of this category of question, withoutfurther input by the programming person, or (b) may lead to additionalchoices which allow the programming person to specify [i] the number ofquestions to be asked, [ii] the difficulty of the question(s), and/or[iii] the actual question(s). The programming person may select morethan one category of questions. By touching “OTHER”, the programmingperson may select other question categories (e.g. a request for time anddate, a logic puzzle, etc.), either (a) from either a menu, or (b) bydirectly entering question material through a keyboard or other inputport.

The second line of buttons allow the programming person to determinetest format issues including the time allowed (either for each question,or for the total set of questions, or both); whether the presentationformat is text, audio or both; and the language to be used for the test.

The third line of buttons allows the programming person to determine thescoring method. For example, the three left buttons in the row allow thesetup person to define a three level score (good/fair/poor), based onthe number of correct answers, which may be weighted in a manner thatproduces a score between 1 and 10. Thus “good” could be defined as ascore of 9 or 10, fair as a score of 6, 7 or 8, and poor as a score of 5or below; These values may be entered by access to a menu which liststhem (upon touching one of the three leftmost boxes of row three), or bya keyboard entry. Touching the “ADVANCED SCORING METHODS” button allowsaccess to more complex scoring techniques, including:

(a) scoring with a greater or lesser number of result possibilities thanthree;

(b) having the score depend on one or more prior patient evaluations;

(c) truncating the evaluation when it is only partially completed, if itis clear that the patient is doing either exceptionally poorly, orexceptionally well;

(d) extending the evaluation, if an indeterminate result is obtained;

(e) truncating the evaluation if either [i] the patent condition istenuous (demanding a quick evaluation) from the start of the evaluation,or [ii] the patient condition deteriorates during the evaluation; and

(f) extending the evaluation if either [i] the patent condition is good(therefore allowing for a more detailed evaluation) from the start ofthe evaluation, or [ii] the patient condition improves during theevaluation.

The fourth row of buttons allows the programming person to determine howsuch evaluation information is to be utilized. The possibilities shown(accessed by touching the respective virtual buttons, for example)include:

(a) using the information for IMD therapy selection (e.g. therapyacceleration or deceleration, in the ICD example discussed hereinabove);

(b) locking out patient access to IMD control for a score which is lessthan a certain value (value to be entered);

(c) contacting the MP for a score which is less than a certain value(value to be entered);

(d) other uses (e.g. the performance of patient evaluations duringnon-critical times, to establish a patient performancebaseline/standard).

As shown in FIG. 10, the results of a patient assessment are transmittedfrom the patient device. Although the format in the figure shows threepossible transmitted results ([i] fully conscious, [ii] intermediatestate of consciousness and [iii] unconscious), many other formats arepossible (e.g. [i] transmitting the actual score, [ii] transmitting theactual patient responses, etc.). As shown in FIG. 11, information aboutthe patient state of consciousness is received by the IMD, inembodiments of the invention in which patient interrogation is afeature.

FIG. 19 shows a control screen 1900 which illustrates one approach todetermining the contribution of each of a plurality of patient devicesensors to an overall patient assessment. In the approach shown in FIG.19, the desired relative weighting of the contribution of each of aplurality of sensors is inputted by the programming person. The FIG. 19illustration shows a linear weighting process among sensors. Non-linearweighting among sensors is also possible, e.g. blood pressure weightedat 500/% of the sum of all sensor contributions (to the overall patientassessment), unless the blood pressure falls below a certain value, inwhich case blood pressure is weighted at a larger percentage than 50.(See discussion below about linear versus non-linear weighting within asensor parameterization format.)

To use the screen 1900, the programming person touches any button in thefirst row corresponding to a sensor in use in the patient device.Touching the any of the six buttons would lead to a menu with choices ofa fractional or percentage value (e.g. 5%, 10%, 15%, etc.). For example,the programming person could enter 75% for blood pressure and 25% forrespiratory rate. If the BP score was 6 and the respiratory rate scorewas 10, this would lead to an overall score of 7.

Other modalities shown in FIG. 19 for possible inclusion in the overallpatient assessment include:

(a) a semi-quantitative assessment of the patient state of consciousnessor cognitive function, as discussed hereinabove;

(b) the heart rate, which may be assessed at the patient device byeither two or more electrodes attached to the patient, by conductiveelements which the patient touches, or by a mechanical or acoustictransducer in the vicinity of one of the large arteries;

(c) a measurement of blood oxygen saturation, content or partialpressure and/or a measure of either blood or end tidal carbon dioxidecontent—each as a measure of the adequacy of patient ventilatoryfunction—which may serve as a supplement to, or instead of a directmeasure of the respiratory rate;

(d) the monitoring of galvanic skin resistance, which could supplementthe functioning of any IMD, when an assessment of sympathetic tone wouldbe useful, and

(e) the monitoring of blood glucose (or tissue glucose) which could beintermittently sampled externally (i.e. by the patient device) forsystems with an automatic (or semi-automatic) implantable insulindelivery apparatus.

If the programming person wishes to use the “autoblend” feature, inwhich the system selects a preset blend for a given sensor mix, he/shecan select either “DEFAULT VALUES WITH PATIENT INTERROGRATION” or“DEFAULT VALUES WITHOUT PATIENT INTERROGATION”, depending on whetherpatient interrogation is to be included in the patient assessment.

The screen is configured to allow for a number of help options for theprogramming person including:

(a) help from a help program including definitions and, possibly,suggestions;

(b) help from the medical expert device (which may be more sophisticatedthan that available on the device which directly supports screen setup);and

(c) live help from a medical professional (if an MD is doing theprogramming). In addition, the programming person may be given theopportunity to view (i) sensor data and (ii) patient interrogation data,from previously managed events, as a basis for setting up new managementparameters. This information may be stored in one or more of the IMD,the patient device, the M.E. device or the remote station.

The bottom row of virtual buttons allows the system user to navigatebetween the screen 1900 and each of:

(a) the main therapy screen 1600 shown in FIG. 16;

(b) the autoblend screen 1700 shown in FIG. 17;

(c) the patient interrogation screen 1800 shown in FIG. 18,

(d) the physiologic sensor blend screen 2000 shown in FIG. 20;

(e) the syncope sensor blend screen 2100 shown in FIG. 21, and

(t) the screen that was in previous use by the programming person.

Embodiments of the invention are possible in which a change in one ormore sensor values (or a change in the weighted sum of all of the sensorvalues) that takes place during a treatment event results in a changein:

(a) the sensor parameterization scheme (e.g. the mathematicalrelationship between blood pressure and the score);

(b) the sensor blending scheme (i.e. the relative weight of eachsensor);

(c) the actual treatment algorithm (e.g. exclusion of one or more tiersof therapy). For example, if the patient interrogation parameterindicated that, during treatment, an ICD patient made a transition fromconscious to unconscious, then regardless of the values of othersensors, each of the low level tiers of therapy (e.g. tier #1, tier #2and tier #3 in the screen configuration shown in FIG. 16) would beskipped, and a high energy shock would be administered.

FIG. 20 shows an example of a setup screen 2000 for 6 types of sensors,in which the programming person may input information which determinesthe mathematical relationship between a physiologic parameter and thescore which represents that parameter. If the relationship is a linearone, i.e. where the equation:

Y=AX+B,

-   -   where Y is the value of the parameter score,        -   X is the value of the parameter        -   A is the sensitivity; and        -   B is the threshold value,            then entering the desired values of threshold and            sensitivity will specify the relationship between the            parameter and the parameter score. For example, the            equation:

blood pressure score=0.2×(systolic blood pressure)−10

generates a relationship between blood pressure score and systolic bloodpressure which is similar to that shown in Table B. To enter such arelationship, the programming person, using the screen shown in FIG. 20would:

(a) touch the “THRESHOLD” button under “BP”, see a sub-menu (not shownin the figures) and select the value “−10”; and

(b) touch the “SENSITIVITY” button under “BP”, see a sub-menu (not shownin the figures) and select the value “0.2”.

The “CURVE” button in each column leads to other options including:

(a) access to the programming of a non-linear relationship betweenparameter values and parameter scores. The programming of a non-linearrelationship could be accomplished by selecting an equation of seconddegree or higher [e.g. Y=CX(sup3)+DX(sup2)+EX+F] and specifying each ofits defining elements [i.e. C, D, E and F, in the example];

(b) selecting from a menu of curves (which may be illustrated in ascreen-in-screen configuration). The menu would include curves withexponential segments, logarithmic segments, parabolic shapes and othershapes,

(c) allowing the programming person to draw, using the touch sensitivescreen, a suitable curve, refine the drawing if necessary, and enterthis shape along with the value of two or more points on the curve;

(d) allowing the programming person to enter two or more pairs of valuesof parameter value and parameter score, after which the programmingperson is presented with a menu of curves which fit these points. Theprogramming person may select one such curve, and/or specify one or moreadditional pairs of values to refine the curve;

(e) access to the programming of segments of a curve or line, which,when such segments are assembled, delineates the full relationshipbetween the parameter value and the parameter score;

(f) entering cutoff values (e.g. in Table B hereinabove, any systolicblood pressure value less than 60 mm. Hg. generates a blood pressureparameter value of “l”);

(g) combinations of (a)-(f).

Alternatively, the programming person may decide to use a defaultrelationship between parameter value and parameter score, which can beselected for any of the sensors by touching “DEFAULT” in the column ofbuttons corresponding to that sensor.

The programming person may define the sensor blend from the screen 2000,using the buttons in the fifth row, in the same manner as was the casefor the first row of buttons for the screen 1900.

For each sensor, the programming person may select an “alert value”,i.e. a parameter score (or parameter value) that results in the alertingof one or more of the IMD system entities. For example, the patient maybe alerted for a glucose value below 70 mg./dl. By touching the buttonin row 6, in the GLUCOSE column, the programming person may enter (a)the value above or below which the alert is triggered, and (b) theentity to be alerted.

Similarly, for each sensor, the programming person may select an “alarmvalue”, i.e. a parameter score (or parameter value) that results in thetriggering of an alarm for one or more of the IMD system entities. Forexample, the patient may be presented with an alarm tone for a glucosevalue below 60 mg./dl. By touching the button in row 7, in the GLUCOSEcolumn, the programming person may enter (a) the value above or belowwhich the alarm is triggered, and (b) the entity to be alarmed. In thesame hypothetical event with blood sugar of 60 mg./dl., the MP may bealerted (programmed as indicated hereinabove) when the patient ispresented with the alarm tone.

The blood gas sensor may determine oxygen, carbon dioxide or anothergas. Screens with fewer, more and with other sensors are possible,

FIG. 21 shows a control screen 2100 for the management of a number ofdevices which may, either individually or in combination, allow for thedetermination or the making of a conditional statement, about whetherthe patient has fallen or has suffered a syncopal episode. Such anarrangement is the subject of FIGS. 19A, 19B, 19F, 19G, 19I and 37 ofU.S. Patent Publication No. US/2007/0043585A1. The devices, areindicated by the headings of columns 2 through 5 of FIG. 21 herein, i.e.

(a) one or more attitude sensors; These indicate the orientation of thepatient's body in space;

(b) one or more accelerometers, which, by the detection of a suddendeceleration, may give evidence of a fall;

(c) one or more piezoelectric devices, which, by the detection of adiscrete impulse, may indicate a fall;

(d) one or more cameras in the environment of the IMD patient, which,with image processing software known in the art, may allow for thedetection of a fall; and

(e) other devices which may make use of one or more of [i] sound, [ii]polarized light, and [iii] the detection of alternating current carryingconductors in a floor, (in FIGS. 19E, 19J and 19H of U.S. PatentPublication No. US/2007/0043585A1.

The values to be entered in each column: “threshold”, “sensitivity”, and“curve”, are conceptually the similar to the methods for such entrydescribed in the specification for FIG. 20. However, since some of thesensors which are the subject of FIG. 21 do not process one dimensionaldata (e.g. systolic blood pressure), but instead process more complexinformation (e.g. camera images), one or more additional steps forconverting the complex information to a score (e.g. a scale of 10reflecting the probability that a camera image or a sequence of suchimages represents a patient fall) will be necessary. The control ofthese steps may be outside the expertise of the MP, MD or otherprogramming person who sets up the IMD system; Alternatively, theprogramming person may be allowed such access, which in turn may bethrough menus obtained by touching the “CURVES” button, or by addingother buttons which allow for such access.

As an alternative to entering threshold, sensitivity and curveinformation, the programming person may decide to use a defaultrelationship between parameter value and parameter score, which can beselected for any of the sensors by touching “DEFAULT” in the column ofbuttons corresponding to that sensor; and which can be selectedsimultaneously for all of the sensors by touching the left most buttonin row five labeled “DEFAULT VALUES”.

The programming person may define the sensor blend from the screen inFIG. 21, using the buttons in the fifth row, in the same manner as wasthe case for the first row of buttons for the screen shown in FIG. 19.Alternatively the programming person may choose to select a defaultblend of the available fall/syncope sensors.

The final step in the setup of fall/syncope detection is the programmingof one or more definitions of one or more levels of certainty that afall/syncopal episode has occurred. For example, if two sensing devicesare operative (e.g. (a) a group of cameras and (b) a group ofaccelerometers), and each group generates a group value indicating, on ascale of ten, the probability that that group of sensors detected asyncopal event, then the programming person might program:

(a) “near certainty of syncope” as a sum of the two sensor group values(with each of the two group values ranging between 1 and 10) totaling 18to 20;

(b) “high likelihood of syncope” as a sum of the two sensor group values(with each of the two group values ranging between 1 and 10) totaling 14to 17; and

(c) “possible syncope” as a sum of the two sensor group values (witheach of the two group values between 1 and 10) totaling 10 to 13.

Many other formats for fall and/or syncope detection will be obvious tothose skilled in the art.

Although most of the FIGS. 16-21 use the ICD and its management asexamples, the concepts embodied could apply to other IMDs and thepatient devices and sensors associated with them.

4.0 Triaging Using Function*

In an IMD system with multiple possible control entities, where eachentity does not review all incoming IMD and/or patient data, methods andmeans of classifying the data in terms of urgency or potential urgencyare necessary, in order to decide when data sharing among systementities is necessary. The classification system allows for datareflecting clinical events that exceed a predetermined level of urgencyto be transmitted to potential control entities for review, in a processreferred to as “notification”. The IMD system described herein makesextensive reference to such notification, e.g. in the communicatedsignals in FIGS. 8-11, in screen FIG. 13, in the examples shown in FIGS.22-24 and 77-82, and among the algorithms shown in FIGS. 29-58(especially FIGS. 53-56B), and in the specification associated with eachof these figures. The level of urgency of a clinical event may beascertained in a straightforward manner if the value of a single, easilymeasurable, physiologic parameter contains enough information for suchdetermination. However, not infrequently, a single parameter-basedevaluation is not as telling as an evaluation based on multipleparameters. For example, the combination of both heart rate and bloodpressure are often more useful for clinical decision making in themanagement of a tachycardia, than is either heart rate or blood pressurealone.

It is therefore useful to have a logical process by which the value oftwo or more physiologic parameters—the “input variables”—are processedto produce one or more “output parameters”, each such output parameterindicating (a) a “notify/do-not-notify” decision or (b) a “treat/donot-treat” decision. Three ways of performing this task are:

(a) a flow diagram-based approach;

(b) setting up a 2×2 matrix for the case of two input variables (and, ingeneral, an N-dimensional, matrix for the case of N input variables),where each cell is defined by a range of values of each of the N inputvariables, and where each cell is assigned one or more outputparameters, each of which indicates either a treat/no-treat decision, ora notify-entity-X/do-not-notify-entity-X decision. Table C and Table Dhereinabove could be easily converted into 2×2 tables with row labelsindicating one input variable (i.e. blood pressure, in the case of TableC) and column labels indicating another input variable (i.e. respiratoryrate in the case of Table C); and with each cell in the 2×2 matrixcontaining a digit ranging from 1 to 10 (each of which digits may beused more than once), each digit indicating the output variable(referred to hereinabove as the “blended assessment”); or

(c) arithmetically manipulating the input variables, so that theygenerate a single value, which reflects the severity of a clinicalsituation. That value is then utilized for notification and treatmentdecisions.

Each of the three approaches will lead to the same results; i.e. usingany of approaches (a)-(c) hereinabove, the values of each of a pluralityof sets of input variables may be matched to values of one or moreoutput parameters. Any particular set of values of input variables isassociated with a single set of treat/no-treat and notify/do-not notifydecisions. The third approach is utilized frequently hereinbelow, andthe arithmetic entity which amalgamates the information about the inputvariables into a single number is referred to as “Function*”. Theassembly of multidimensional clinical information into a singleparameter reflecting the need for and the urgency of treatment mirrorshow physicians deal with urgent clinical situations. The use ofFunction* for decision making may be viewed as an arithmetic method ofcarrying out the triaging process. FIGS. 22A-24 illustrate the use ofFunction* in making treatment and notification decisions. Function* isfurther examined in FIGS. 71A-76C and the associated specification (andis also a consideration in FIGS. 60, 62, 65 and 67 and the associatedspecification). In the examples of Function* shown in FIGS. 22A and 22B,Function* is simply a restatement of a clinical parameter value; In theexamples shown in FIGS. 23 and 24, Function * is a more detailed entity.

The example shown in FIG. 22A considers treatment and notificationdecisions in an ICD. Function* is identical to the heart rate. Themulti-tier treatment/notification format is similar to that used inFIGS. 5A and 5B of U.S. Patent Publication No. US/2008/0300659. FIG. 22Aherein indicates:

(a) ICD therapy (viz. bradycardia pacing) for heart rate of less than 60b.p.m.;

(b) no treatment for heart rates between 60 and 125 b.p.m.;

(c) patient notification, but no treatment, for heart rates between 125and 150 b.p.m.;

(d) ICD treatment, without notification, for heart rates between 150 and240 b.p.m.; and

(e) both ICD treatment and MP notification, for heart rates above 240b.p.m.

In the case of FIG. 22A and each similarly formatted figure, neither thefigure nor the discussion dwell on the subtlety of whether heart rateswhich are exactly at the border between zones (e.g. 60, 125, 150 and 240b.p.m in the case of FIG. 22A) are to be associated with the managementzone above or the management zone below the border; a decision whichdoes not affect the conceptual basis of the approach.

FIG. 22B shows an example of an implantable blood sugar managementdevice in which:

(a) the patient and the MP are notified for a blood sugar of less than40 mg./dl.;

(b) the patient (but not the MP) is notified for a blood sugar between40 and 65 mg./dl.;

(c) there is no treatment or notification for blood sugar values between65 and 120;

(d) the implanted device manages the blood sugar without notification,for blood sugar values between 120 and 160 mg./dl.;

(e) the implanted device manages the blood sugar and notifies thepatient, for blood sugar values between 160 and 350 mg./dl.; and

(f) the implanted device manages the blood sugar and notifies both thepatient and the MP, for blood sugar values greater than 350 mg/dl.; FIG.23 shows each of:

(a) an example of a more complex Function*;

(b) a two dimensional contingency table which contains the samerelationships between the input variables (heart rate and ICD shockfrequency), and the output (variables treatment and MP notification);

(c) a text summary of ICD operation based on either (a) or (b).

The rationale for the treatment and notification format is:

-   -   (a) MP notification may be desirable for a very severe        tachycardia;    -   (b) MP notification may be desirable for a less severe        tachycardia if it is recurring; and    -   (c) MP notification may be desirable for an even less severe        tachycardia if it is recurring on a frequent basis.

In the algorithm used in the example, a tachycardia which occurs within24 hours of a previous ICD shock is considered to be of greater concern,and a tachycardia which occurs within 20 minutes of a previous ICD shockis considered to be of even greater concern. These heightened levels ofconcern are used to lower the threshold for MP notification from a basevalue of notification at 250 b.p.m., to gradually lower notificationthresholds values until, with multiple shocks as described hereinbelow,MP notification occurs with a tachycardia at 180 b.p.m.

As indicated in the figure:

FUNCTION*=A·(10+2B+C)

where: A=Heart Rate for rates ≥180 b.p.m., and

-   -   A=0 for rates <180 b.p.m.    -   B=# of ICD shocks in past 24 hours, and    -   C=# of ICD shocks in part 20 minutes

The box on the left side of the figure shows an operating format whichis defined by the selection of which actions are to be associated withwhich values of Function*. In the case shown:

(a) There is no treatment for values of Function* less than 1800;

(b) The ICD functions autonomously for values of Function* between 1800and 2500; and

(c) The ICD treats the tachycardia and notifies the MP for values ofFunction * above 2500.

A text statement of the operation of the algorithm, appearing at thebottom of the figure states:

(a) MP notification occurs for:

(i) heart rate >250 b.p.m., without a shock within the last 24 hr.;

(ii) heart rate ≥228 b.p.m., with 1 shock delivered between 20 min. and24 hr. in the past;

(iii) heart rate ≥209 b.p.m., with either [a] 2 shocks, each deliveredbetween 20 min. and 24 hr. in the past, or [b] 1 shock delivered withinthe last 20 min.;

(iv) heart rate ≥193 b.p.m., with either [a] 3 shocks, each deliveredbetween 20 min. and 24 hr. in the past, or [b] 1 shock delivered between20 min. and 24 hr. in the past and 1 shock delivered within the last 20min.; and

(v) heart rate >180 b.p.m. with either [a] 4 or more shocks deliveredbetween 20 min. and 24 hr. in the past, or [b] 3 or more shocksdelivered between 20 min. and 24 hr. in the past and 1 shock deliveredwithin the last 20 min. or [c] 2 or more shocks delivered within thelast 20 min.; and

(b) ICD therapy is triggered by a heart rate >180 b.p.m.

The 6 row by 5 column contingency table on the right side of the figureshows an operating format whose performance is identical to that of theFunction* discussed herein.

Although the contingency table format readily illustrates systemperformance when the number of parameters is limited, it becomesunwieldy as soon as another parameter is added, and virtually impossibleto display if yet another parameter is added. For example, one mayconsider the case where treatment and notification depend on (a) heartrate, (b) shock number, and (c) respiratory rate: A three dimensionaltable would be needed to show the contingencies. Alternatively theycould be shown in a set of two dimensional tables, one for each value ofthe respiratory rate parameter. By way of further example, if the priorshock history were in a more complex algebraic format (than 2B+C in FIG.23) and depended on a not-easily-lumped B and C parameter, then theinclusion of respiratory rate would require a table with a highlyrepetitive two dimensional structure, because of (a) the impossibilityof visualizing a four or more dimensional table, and (b) the difficultyof dealing with multiple three dimensional tables.

FIG. 24 shows an example in which Function* is used to blend (a) heartrate and (b) a parameter with four possible values which indicates thelikelihood of a syncopal episode (e.g. based on sensors which might beused in conjunction with the screen shown in FIG. 21). The possibilityof syncope causes the operating format to be more reactive to a givenrate of tachycardia, where more reactivity refers to a lowering of eachof (a) the threshold for interrogating a patient, (b) the threshold fortreatment, and (c) the threshold for MP notification. In the exampleshown, the greater the degree of certainty that a syncopal episode hasoccurred, the greater the lowering of the threshold for each of patientinterrogation, treatment and MP notification.

The figure layout parallels that of FIG. 23, i.e. the upper leftillustrates Function*, the upper right illustrates a contingency tablewhich illustrates the same operating format as the Function* to itsright, and the lower part of the figure summarizes the operation of thesystem in text/tabular format.

As indicated in the figure:

FUNCTION*=D+E

where D=Heart Rate (b.p.m.)−70

E=80·(−1+[Sensor Value]sup0.2),

and Sensor Value=1 indicates nil chance of patient fall

Sensor Value=2 indicates possible patient fall

Sensor Value=3 indicates high likelihood of patient fall

Sensor Value=4 indicates near certainty of patient fall

The box on the left side of the figure shows an operating format whichis defined by the selection of which actions are to be associated withwhich values of Function*. In the case shown:

(a) There is no treatment for values of Function* less than 76,

(b) For values of Function* between 76 and 96, the ICD interrogates thepatient, and, based on the interrogation, makes a decision about whetheror not to treat the tachycardia (and/or whether to apply a particularlygentle form of treatment);

(c) The ICD functions autonomously for values of Function* between 96and 156; and

(d) The ICD treats the tachycardia and notifies the MP for values ofFunction * above 156.

Examples of tachycardias which might be appropriate for such patientassisted analysis are:

(a) a tachycardia which may or may not be sinus tachycardia, and where apatient explanation of circumstances or indication of very goodtoleration would argue for non-aggressive management; and

(b) a tachycardia which may be treated with either an aggressive (e.g.shock) or gentle (e.g. ATP) approach, where the selection is based onpatient toleration.

The text/tabular summary at the bottom of the figure shows that for thisexample, the effect of increasing likelihood of syncope results in adecrease in the triggering heart rate of 12, 20 or 26 beats per minute(depending on the likelihood of syncope) for each of patientinterrogation, ICD treatment and MP notification.

The table on the right side of the figure illustrates all possiblecontingencies for this example of Function * and the 4-level response tothe Function* values.

Numerous other examples of the use of Function* will be obvious to thoseskilled in the art. Some are shown in FIGS. 71A-76C. Some examples ofcomplex IMD management scenarios are shown in FIGS. 77-82.

5.0 Patient Assessment Algorithms

FIGS. 25 and 26 show algorithms for the use of cognitive information byeither the IMD (FIG. 25) or the MP (FIG. 26). The hardware for obtainingthe information is shown in FIGS. 4 and 6. Signal traffic carrying suchinformation is shown in FIGS. 8-11. Whereas FIGS. 18 (and 17 and 19)discuss the use (for treatment decision making) of an already completedpatient interrogation, FIG. 25 shows the processing of informationobtained from patient interrogation in real time.

Referring to FIG. 25, if the IMD is programmed for a mode of therapy inwhich a knowledge of the patient cognitive state is useful fordetermination of the aggressiveness of therapy, the IMD sends a promptto the patient requesting a response. If the IMD does not receive aresponse within a given time interval t1, the assumption is made thatthe patient is not capable of a response, e.g. because of a dire medicalstate (though the non-response could be for other reasons [e.g. patientnot in proximity to patient device]), and the IMD selects an aggressivetherapy (e.g. a high energy shock, in the case of an ICD detecting atachycardia). If the IMD receives a response to the prompt, optionsinclude:

(a) accept the response as evidence that the patient condition is goodenough for the selection of a non-aggressive therapy (e.g. burst pacing,in the case of an ICD detecting a tachycardia); and

(b) ask the patient a test question, and utilize the quality of theresponse to the test question for further decision making.

The programming and use of such questions to assess the patientcognitive state is discussed hereinabove in conjunction with FIG. 18.The physical source of the question and the evaluation of the responsemay be the IMD, the patient device or both (with the two units operatingin a complementary fashion).

The response to the aforementioned question may be classified as good,fair or poor (or classified in a format with two or with more than threecategories of response). If good, then non-aggressive IMD treatment isthe result; If poor, then aggressive treatment is the result; If fair,then either:

(a) the IMD may then select either aggressive or non-aggressivetreatment, especially if there is time-pressure to make such a decision;or

(b) the patient may be asked an additional question.

In similar manner to the algorithm response to the first question, theresponse to the second question may be classified as good, fair or poor(or classified in a format with a different number of categories ofresponse). If good, then non-aggressive IMD treatment is the result; Ifpoor, then aggressive treatment is the result; If fair, then either:

(a) the IMD may then select either aggressive or non-aggressivetreatment;

(b) the patient may be asked an additional question, after which thealgorithm proceeds as indicated herein for the response to the secondquestion;

(c) the IMD may contact the MP for further guidance (who may then reviewthe results of the interrogation as well as the medical situation inprogress which necessitated the interrogation); or

(d) the IMD may request the evaluation of either [i] the patient device(as indicated by the specification in conjunction with FIG. 18[concerning cognitive issues] and FIGS. 17 and 19-21 [concerningnon-cognitive patient assessment issues]), or [ii] the M.E. device (e.g.concerning one or more prior experiences [of this patient or others]with similar circumstances).

The algorithm shown in FIG. 25 could, with essentially nothing more thanlabeling changes (in which “patient device” and “IMD” are switched)would illustrate a patient interrogation algorithm performed by thepatient device itself (rather than the interrogation conducted by theIMD described hereinabove, in which the patient device acts as aninterface between the IMD and the patient). In such a figure conversion,the boxes in the figure original FIG. 25 which indicate the IMDselecting therapy, would indicate either (a) that the patient deviceselects therapy, or that the patient device provides its information tothe IMD, so that the IMD may make the therapy selection.

FIG. 26 shows an algorithm in which an MP, in the process of managing aclinical situation determines that he/she would make a better decisionwith more knowledge of the patient's mental state. The MP sends a promptto the patient requesting a response. If the MP does not receive aresponse within a given time interval t2, the assumption is made thatthe patient is not capable of a response, and the MP selects anaggressive therapy. If the MP receives a response to the prompt, optionsinclude:

(a) accept the response as evidence that the patient condition is goodenough for the selection of a non-aggressive therapy;

(b) the MP utilizes the pre-programmed test question feature of thepatient device (see FIGS. 18 and 25) to further assess the patient, andutilizes the quality of the response to the test question(s) for furtherdecision making; and

(c) the MP converses with the patient (preferably by audio, if not, thenby text messaging), and utilizes the quality of the patient responsesfor further decision making.

If option (b) is selected, the response to the aforementionedquestion(s) may be classified as good, fair or poor (or classified in aformat with two or with more than three categories of response). Ifgood, then non-aggressive IMD treatment is the result; If poor, thenaggressive treatment is the result; If fair, then either:

(i) the MP may then select either aggressive or non-aggressivetreatment, especially if there is time-pressure to make such a decision;

(ii) the patient may be asked an additional question;

(iii) the MP may elect to give control of the IMD to either of the IMD,the patient device, or the M.E. device;

(iv) the MP may check the therapy recommendation of one or more of theIMD, the patient device, or the M.E. device;

(v) in unusual circumstances, the MP may elect to give control of theIMD to the patient; or

(vi) the MP may choose to further evaluate the patient by conversingwith him/her. The result of the conversation may then be classified asgood, fair or poor (or in a truncated or expanded format with greater orfewer response categories, respectively). If good, then non-aggressiveIMD treatment is the result; If poor, then aggressive treatment is theresult; If fair, then any of options (i) (v) hereinabove may beselected.

If option (c) is selected, the response to the aforementionedconversation may be classified as good, fair or poor. If good, thennon-aggressive IMD treatment is the result; If poor, then aggressivetreatment is the result; If fair, then

(1) the MP may select any of options (i), (iii), (iv) or (v),

(2) the MP may utilizes the pre-programmed test question feature of thepatient device to further assess the patient, and utilize the quality ofthe response to the test question(s) for further decision making. Theresult of the pre-programmed question evaluation may then be classifiedas good, fair or poor. If good, then non-aggressive IMD treatment is theresult; If poor, then aggressive treatment is the result; If fair, thenany of options (i), (iii), (iv) or (v) hereinabove may be selected.

Many other formats for patient evaluation are possible and will beobvious to those skilled in the art. They will be substantiallydependent on the amount of time available for such evaluation; At timesthe evaluation may need to be truncated if the IMD or one or moresensors indicate a deteriorating patient condition.

6.0 System Architecture Summary

FIG. 27A and FIG. 27B, Tables 1A and 1B respectively, show a partiallist of the source of control in two, three, four and five entity IMDsystems. The entities are selected from the list:

(1) the MP,

(2) the medical expert device,

(3) the patient,

(4) the patient device, and

(5) the IMD (which, if it runs parallel treatment decision algorithms,may be considered as multiple entities, one for each such algorithm).

The simplest systems are the two entity systems, where control is byeither the IMD or by one of (a) the MP, (b) the M.E. device, (c) thepatient, or (d) the patient device. The final two entity entry in thetable refers to an IMD in which more than one algorithm may run, andwhere each of two algorithms may be the source of a treatment decision.Two entity systems include:

systems involving the IMD and the patient, the subject of FIGS. 46-69herein;

systems involving the IMD and the MP, the subject of U.S. PatentPublication Nos.

US/2007/0043585A1, US/2007/0299473, US/2008/0058884, US/2008/0300659,and Provisional Patent Application 61/204,957; and

systems involving the IMD and an M.E. device, the subject of U.S. PatentPublication No. US/2008/0300659.

Three entity systems are the subject of 19 of the 29 algorithmsdiscussed in conjunction with FIGS. 29 to 56B. They include:

an important system configuration: the IMD/patient/MP system [FIGS.29-37 and 53-55 herein], also discussed in U.S. Patent Publication No.US/2008/0300659;

the IMD/patient/patient device system [FIGS. 38-43 herein]; and

the IMD/M.E. device/MP system discussed in U.S. Patent Publication No.US/2008/0300659, and (c) a number of system architectures with multipleIMD algorithms.

Four entity systems include the important system configuration which isa variation of IMD/patient/MP: IMD/patient device/patient/MP system. Asseen in the table, the number of system configurations with multiple IMDalgorithms running in parallel increases geometrically as the number oftotal entities increases,

Five entity systems are shown in Table 1B/FIG. 27B. The important entryIMD/patient device/patient/M.E. device/MP is the subject of thealgorithms shown in FIGS. 50-52, 56A and 56B, and is extensivelydiscussed in conjunction with specification concerning system hardware,screens and examples. A partial list of the large number ofconfigurations with multiple IMD algorithms is shown in the five entrysection of the table.

FIG. 27C shows a 2×2 table for the control of an IMD which may be eitherinternally controlled or externally controlled, with 4 possibleoperating states. The states are defined by each of two parameters: (i)the source of moment-to-moment control, which may be internal orexternal, and (ii) the highest priority source of control, which may beinternal or external and need not be the same as the source ofmoment-to-moment control. Specifically:

(a) in the state in which the internal processor is bothmoment-to-moment controller and the highest priority controller, we havethe function of a classic IMD such as a pacemaker. (The actual figuredoes describe such a classic IMD, since these devices are notprogrammable to be in each of the four states delineated by the figure;

(b) in the state in which the internal processor is the moment-to-momentcontroller but the external control station has the highest priority, wehave an IMD whose operation can be overruled by an external controlsource;

(c) in the state in which the external processor is bothmoment-to-moment controller and the highest priority controller, we havethe function of a classic EMD (external medical device). As indicated inthe case of (a) above, the figure does not describe a classic EMD, whichis not programmable to each of the other three states indicated herein;

(d) in the state in which the external processor is the moment-to-momentcontroller but the internal control station has the highest priority, wehave an externally controlled medical device whose operation can beoverruled by an internal control source. An example of such a situationwould be one in which the device is primarily patient controlled, but inwhich the device may, under certain circumstances overrule the patient(e.g. if patient use of the device is deemed to be inappropriate). Morecomplex examples are described in conjunction with FIGS. 77 to 82,

7.0 System Management Algorithms, Overview

FIG. 28 shows Table 2: Classification of Some Possible SystemAlgorithms. These algorithms are examples—some specific and somegeneral—of flow diagrams showing where patient abnormalities aredetected and analyzed, and the process by which an entity is selected tocontrol the management of the abnormality. The flow diagrams arepresented in FIGS. 29 to 56B.

7.1 3-Entity Systems with IMD, Patient and Medical Professional

FIGS. 29-33 involve primary monitoring at the IMD, and selection of oneof three control entities (the IMD, the patient or the MP) by each offive possible agents. FIGS. 34-37 parallel FIGS. 29 to 33, but involveprimary monitoring at the patient device, and selection of one of threeaforementioned control entities by each of four possible agents.

FIGS. 38-40 involve primary monitoring at the IMD, and selection of oneof three control entities (the IMD, the patient device or the patient)by each of three possible agents. FIGS. 41-43 parallel FIGS. 38 to 40,but involve primary monitoring at the patient device, and selection ofone of three aforementioned control entities by each of three possibleagents.

FIGS. 44 and 45 are generalized algorithms for IMD systems with threeentity control. In FIG. 44, the entity which does the primary monitoringalso determines the choice of control entity. In FIG. 45, the entitywhich does the primary monitoring is not the first choice fordetermining the choice of control entity.

FIGS. 46-49 show algorithms for IMD systems with two possible controlentities; while FIGS. 50-52 show systems with five possible controlentities. Each of FIGS. 46-52 is structurally similar to the threeentity flow diagrams of FIGS. 29-45. FIGS. 53-56B show flow diagramswith a substantially different format than those of FIGS. 29-52.

FIG. 53 shows a flow diagram in which the IMD is the default controlsource, and in which either of the patient or the MP may overrule theIMD.

FIGS. 54 and 55 show another approach in which the hierarchy among theMP, the patient and the IMD are predetermined, i.e. determined inadvance by system programming, although the choice of entity whichactually controls a particular situation will also depend on whichnotification criteria are met, and may depend on whether the MP or thepatient chooses to exercise control.

FIGS. 56A and 56B show five entity versions of the algorithms shown inFIGS. 54 and 55. FIG. 56B illustrates a flow diagram which shows how thecontrol screen in FIG. 14 may control a five-entity IMD system.

FIG. 29 shows an algorithm for management of a system with an IMD, apatient with patient device and an MP. Signals are monitored primarilyat the IMD. If an abnormality is detected which requires therapy, adecision is made by the IMD as to which of the IMD, the patient or theMP will be the source of control. The decision may be based on apre-selected format, e.g. the IMD ideally manages the abnormality forstraightforward situations, and in non-straightforward situations, itselects the patient, unless the patient is unavailable, in which case itselects the MP; Many other divisions of management responsibility arepossible, and are discussed hereinabove and hereinbelow in sectionsrelated to notification of the other entities which may serve as asource of control (see the specification which discusses FIGS. 71A to76C). Alternatively, rather than basing the selection of control agenton a pre-selected format, the IMD may make a selection based on“secondary information,” i.e. information which comes from a sourceother than the primary source; In such an instance the primary (IMDsensor) information would be augmented by the secondary (patient device)information, concerning the current condition (either physiologic,cognitive or both) of the patient.

In the algorithm shown in FIG. 29, if the IMD determines that therapy iswarranted and the IMD selects IMD management, it proceeds with its ownpre-programmed management algorithm. If it determines that therapy iswarranted and selects patient management, then before therapy canproceed, it must be determined if the patient is available. Availabilitycan refer to:

(a) the adequacy of communications between the IMD and the patientdevice;

(b) the patient being in proximity to the patient device;

(c) whether the patient has the ability, as the result of his/hercurrent medical state, to perform the required decision making function;and

(d) whether the patient is willing to perform the management function.

The IMD, through the patient device, queries the patient to determineavailability. It could also directly indicate to the patient that apatient input is requested by notifying the patient directly from theIMD, by either the emission of a tone, or a vibration. If the patient isavailable, the information is presented to the patient. If appropriate,the patient receives the information, selects a treatment via thepatient device, which transmits control signals indicative of the choiceto the IMD. The IMD then executes the treatment ordered by the patient.If the patient is unavailable, the IMD then selects either the MP or theIMD as the source of control.

If the IMD determines that therapy is warranted and the MP is selectedas the source of control (either because this was the IMD first choice,or because the IMD chose the patient, but the patient was unavailable,and the IMD then chose the MP), the IMD transmits information to the MPsufficient to allow the MP to make a management decision. The MPreceives the information, and selects the therapy (including thepossibility of selecting no therapy). The MP then transmits theappropriate control signals to the IMD, allowing for execution of the MPchoice. Not shown in this algorithm, but the subject of the patent andapplications incorporated herein by reference (and also discussed inconjunction with FIGS. 44 and 78 hereinbelow), in the event thatcommunication with the MP is impaired or is not possible, the IMD mayseek other remedies including (a) managing the situation according toits preprogrammed algorithm, (b) contacting the patient (if this was notalready tried), and (c) continuing to try to contact the MP.

FIG. 30 shows an algorithm for management of a system with an IMD, apatient with patient device, and an MP, in which the choice ofcontrolling agent occurs at the patient device. Signals are monitored atthe IMD. If an abnormality is detected which may require therapy,signals are transmitted to the patient device, where a decision is madeby the patient device as to whether therapy is warranted, and if it is,as to which of the IMD, the patient or the MP will be the source ofcontrol. The transmitted signals will preferably carry informationobtained by the sensors in the IMD (including one or more of (a) rawsensor data, (b) processed sensor data, and (c) data indicative of thetherapy selection/recommendation by the IMD algorithm[s]), and may carryadditional information, such as the latest programming of the IMD. Thepatient device decision may be based on a pre-selected format, or it maymake a selection based on recently obtained information which thepatient device has access to, concerning the current condition (eitherphysiologic, cognitive or both) of the patient.

In the algorithm shown in FIG. 30, if therapy is warranted and thepatient device selects IMD management, it signals the IMD to proceedwith the IMD pre-programmed management algorithm. If therapy iswarranted and the patient device selects patient management, then beforetherapy can proceed, it must be determined if the patient is available.The patient device queries the patient to determine availability. If thepatient is available, the information is presented to the patient. Thepatient receives the information, selects a treatment via the patientdevice, which transmits control signals indicative of the choice oftherapy to the IMD. The IMD then executes the treatment ordered by thepatient. If the patient is unavailable, the patient device then selectseither the MP or the IMD as the source of control.

If therapy is warranted and the MP is selected as the source of control,the patient device and/or the IMD transmits information to the MPsufficient to allow the MP to make a management decision. The MPreceives the information, and selects the therapy. The MP then transmitsthe appropriate control signals to the IMD, allowing for execution ofthe MP choice. The aforementioned reference to possible remedies forinadequate communication with the MP apply.

FIG. 31 shows an algorithm for management of a system with an IMD, apatient with patient device, and an MP, in which the patient is giventhe option of making the choice of which entity is in control. Signalsare monitored at the IMD. If an abnormality is detected which mayrequire therapy, signals are transmitted to the patient via the patientdevice, and then patient availability is determined. If the patient isavailable, a decision is made by the patient as to whether therapy iswarranted, and if it is, as to which of the IMD, the patient or the MPwill be the source of control. Information available to the patientincludes the aforementioned IMD-based sensor and programminginformation, patient device-based sensor information, and the patient'sknowledge of how he/she is feeling, and his/her attitude about thevarious available therapeutic options. The patient reviews theinformation, and makes the aforementioned decision(s). If the patientdetermines that treatment is warranted and selects himself/herself asthe treatment agent, the patient selects their choice of therapy andindicates it via that patient device, which transmits control signalsindicative of the choice to the IMD. The IMD then executes the treatmentordered by the patient. If the patient is not available, the patientdevice (or, not indicated in the figure, the IMD) makes a selection ofeither the IMD or the MP, the selection being based on either apre-programmed format, on information obtained by the patient device (orthe IMD) at the time that the decision is made, or both.

In the algorithm shown in FIG. 31, if the patient determines thattreatment is warranted and selects IMD management, the patient devicesignals the IMD to proceed with the IMD pre-programmed managementalgorithm. If the patient determines that treatment is warranted andselects the MP, the patient device and/or the IMD transmits informationto the MP sufficient to allow the MP to make a management decision. TheMP receives the information, and selects the therapy. The MP thentransmits the appropriate control signals to the IMD, allowing forexecution of the MP choice.

FIG. 32 shows an algorithm for management of a system, with an IMD, apatient with a patient device, and a medical expert device, in which theM.E. device is given the option of choosing which entity is in control.Signals are monitored at the IMD. If an abnormality is detected whichmay require therapy, signals are transmitted to the medical expertdevice, where a decision is made by the M.E. device as to whethertherapy is warranted, and, if it is, as to which of the IMD, the patientor the M.E. device will be the source of control. The transmittedsignals will preferably carry information obtained by or processed fromthe sensors in the IMD, and may carry additional information, such asthe latest programming of the IMD, and information from the patientdevice (either transmitted via the IMD, or directly from the patientdevice to the M.E. device). The M.E. device decision will be based onone or more of:

(a) information obtained from the IMD

(b) information obtained from the patient device [including one or moreof physiologic and cognitive information], and

(c) information obtained from the M.E. device database, including one ormore of:

-   -   (i) information about the past performance of the actual IMD        which is implanted in the patient    -   (ii) information about the past performance of the same model of        IMD in other patients    -   (iii) information about the past performance of any actual        associated hardware (e.g. a defibrillator lead wire) which is        implanted in the patient    -   (iv) information about the past performance of the same model of        associated hardware in other patients    -   (v) information from a library of electrograms from this patient        and/or other patients    -   (vi) information about this patient's last known medication list        and dosages, vis-à-vis their effect on current management    -   (vii) information about this patient's past medical history    -   (viii) information about the preferences of this patient's        physician.        The M.E. device may also consult with the MP.

In the algorithm shown in FIG. 32, if the M.E. device determines thattreatment is warranted and selects IMD management, it signals the IMD toproceed with the IMD pre-programmed management algorithm. If the M.E.device determines that treatment is warranted and selects patientmanagement, then before therapy can proceed, it must be determined ifthe patient is available. The patient is queried by the patient deviceto determine availability. If the patient is available, the informationis presented to the patient. The patient receives the information,selects a treatment via the patient device, which transmits controlsignals indicative of the choice of therapy to the IMD. The IMD thenexecutes the treatment ordered by the patient. If the patient isunavailable, the M.E. device then selects either the M.E. device or theIMD as the source of control.

If the M.E. device determines that treatment is warranted and selectsitself as the source of treatment management, it selects the therapy andthen transmits the appropriate control signals to the IMD. In the eventof inadequate communication with the M.E. device, the remedies areanalogous to the aforementioned remedies for inadequate communicationwith the MP.

Not shown as a separate figure, but analogous to FIG. 32, is analgorithm in which the M.E. device selects a control agent from thegroup: (a) IMD, (b) patient, and (c) MP. In such an algorithm, if theM.E. device selected the MP as the control agent, the MP would need tobe supplied with sufficient information to make a therapeutic decision.A four agent algorithm is also possible, in which the M.E. deviceselects a control agent from the group: (a) IMD, (b) patient, (c) M.E.device and (d) MP (See the first listing under “4 entity systems” inTable 1a/FIG. 27A.). Five entity systems are the subject of FIGS. 50-52,56A and 56B, and the associated specification.

FIG. 33 shows an algorithm for management of a system with an IMD, apatient with a patient device, and an MP, in which the MP is given theoption of choosing which entity is in control. Signals are monitored atthe IMD. If an abnormality is detected which may require therapy,signals are transmitted to the MP, who determines if therapy iswarranted, and if it is, makes a decision as to which of the IMD, thepatient or the MP will be the source of control. (The case of anunreachable MP has already been discussed hereinabove, and is alsoaddressed in conjunction with FIGS. 44 and 78 hereinbelow.) Thetransmitted signals will carry the aforementioned information from theIMD, and may carry additional information from the patient device. TheMP decisions may be based on a pre-selected format, or he/she may make aselection based on information which the patient device providesconcerning the current condition (either physiologic, cognitive or both)of the patient; or the MP decision may be based on the MP (a) experiencewith this particular patient, (b) experience with the device that thepatient has, (c) experience with the current abnormality that thepatient has, (d) experience with the current medications taken by thepatient, (e) awareness of current medical literature and developments,or (f) a combination of two or more of (a)-(e). The MP may also makehis/her decision after consulting the M.E. device database.

In the algorithm shown in FIG. 33, if the MP determines that treatmentis warranted and selects IMD management, he/she signals the IMD toproceed with the IMD pre-programmed management algorithm. If the MPdetermines that treatment is warranted and selects patient management,then the patient is queried by the patient device to determineavailability. If the patient is available, the appropriate informationis presented to the patient. The patient receives and reviews theinformation, selects a treatment via the patient device, which transmitscontrol signals indicative of the choice of therapy to the IMD. The IMDthen executes the treatment ordered by the patient. If the patient isunavailable, the MP then selects either the MP or the IMD as the sourceof control.

If the MP determines that treatment is warranted and self selects, thenhe/she goes on to select the appropriate treatment, and then transmitsthe corresponding control signals to the IMD, allowing for execution ofthe MP choice.

Whereas FIGS. 29-33 show algorithms in which the monitoring ofinformation at the IMD may initiate a therapeutic action, FIGS. 34-37show four algorithms in which monitoring of information at the patientdevice may initiate such an action.

FIG. 34 shows an algorithm for management of a system with an IMD, apatient with patient device and an MP, in which the decision to considertreating an abnormality takes place at the patient device. Thisalgorithm is analogous to the one shown in FIG. 29, since in bothalgorithms and figures, the choice of which of three entities does thetreating takes place at the IMD, but in the FIG. 29 algorithm, thedecision to consider treatment takes place at the IMD. A decision toconsider treatment may occur at the patient device (FIG. 34) rather thanat the IMD (FIG. 29) in a case where sensors inputting the patientdevice indicate a dire patient state, which may be undetected by theIMD.

If an abnormality is detected at the patient device which may requiretherapy, information about the patient device observation is transmittedto the IMD. At the IMD, a decision is made as to whether treatment iswarranted. The decision may be based on (a) the information transmittedby the patient device, (b) information derived from the IMD sensor(s),or (c) both (a) and (b). If the decision is to treat, the IMD makes adecision as to which of the IMD, the patient or the MP will be thesource of control. The decision may be based on a pre-selected format(e.g. the IMD ideally manages the abnormality for straightforwardsituations, and in non-straightforward situations, it selects thepatient, unless the patient is unavailable, in which case it selects theMP), or it may make a selection based on information which the patientdevice has provided, concerning the current condition (eitherphysiologic, cognitive or both) of the patient.

In the algorithm shown in FIG. 34, if the IMD determines that treatmentis warranted and selects IMD management, it proceeds with its ownpre-programmed management algorithm. If it determines that treatment iswarranted and selects patient management, then it queries the patient todetermine patient availability for management of the current event. Ifthe patient is available, the information is presented to the patient.The patient receives the information, selects a treatment via thepatient device, which transmits control signals indicative of the choiceto the IMD. The IMD then executes the treatment ordered by the patient.If the patient is unavailable, the IMD then selects either the MP or theIMD as the source of control.

If the IMD determines that treatment is warranted and the MP isselected, the IMD transmits information to the MP sufficient to allowthe MP to make a management decision. The MP receives the information,and selects the therapy (including the possibility of selecting notherapy). The MP then transmits the appropriate control signals to theIMD, allowing for execution of the MP choice.

FIG. 35 shows an algorithm for management of a system with an IMD, apatient with patient device, and an MP. Signals are monitored at thepatient device. If an abnormality is detected which requires therapy, adecision is made by the patient device as to which of the IMD, thepatient or the MP will be the source of control. Additional informationmay be requested from the IMD (as shown in FIG. 10).

In the algorithm shown in FIG. 35, if the patient device selects IMDmanagement, it sends signals to the IMD which allow the IMD to make atherapeutic decision. An example of this, VT associated with syncope,where (a) the VT rate is less than programmed the detect rate of an ICD,(b) the patient device detects the untreated but symptomatic tachycardiaand selects the ICD to treat; and (c) the ICD treats the tachycardia, isdiscussed hereinbelow, in conjunction with FIG. 79.

If the patient device selects patient management, then the patientdevice queries the patient to determine availability. If the patient isavailable, the information is presented to the patient. The patientreceives the information, selects a treatment via the patient device,which transmits control signals indicative of the choice of therapy tothe IMD. The IMD then executes the treatment ordered by the patient. Ifthe patient is unavailable, the patient device then selects either theMP or the IMD as the source of control.

If the MP is selected, the patient device transmits information to theMP to allow the MP to make a management decision. The patient deviceinformation may be augmented by information transmitted from the IMD tothe MP, at the request of either the MP or the patient device. The MPreceives the information, and selects the therapy. The MP then transmitsthe appropriate control signals to the IMD, allowing for execution ofthe MP choice. The aforementioned remedies for inadequate communicationwith the MP apply. An example of this, VT associated with syncope, where(a) the VT rate is less than programmed the detect rate of an ICD, (b)the patient device detects the untreated but symptomatic tachycardia andselects the MP to treat; and (c) the MP treats the tachycardia, isdiscussed hereinbelow, in conjunction with FIG. 80.

FIG. 36 shows an algorithm for management of a system with an IMD, apatient with patient device, and an MP, in which the patient is giventhe options of deciding whether therapy is warranted, and if it is, ofmaking the choice of which entity is in control. The algorithm isanalogous to that of FIG. 31, but differs in that FIG. 31 entailsprimarily monitoring at the IMD, while FIG. 36 entails primarilymonitoring at the patient device. If an abnormality is detected whichmay require therapy, signals are transmitted to the patient via thepatient device, and then patient availability is determined. If thepatient is available, a decision is made by the patient as to whethertreatment is warranted, and if warranted, as to which of the IMD, thepatient or the MP will be the source of control.

Information available to the patient includes patient device-basedsensor information, and the patient's knowledge of how he/she isfeeling, and his/her attitude about the various available therapeuticoptions; It may also include information sent by the IMD. Options forproviding IMD information include:

(a) only providing information when requested by outside agent/entity(e.g. the patient or the patient device); and/or

(b) provide information to outside agent if pre-programmed notificationcriteria are met for that agent.

The patient reviews the information, determines if treatment iswarranted, and if it is, selects a treatment agent via the patientdevice. If the patient determines that treatment is warranted andselects himself/herself as the treatment agent, the patient selectstheir choice of therapy and indicates it via that patient device, whichtransmits control signals indicative of the choice to the IMD. The IMDthen executes the treatment ordered by the patient. If the patient isnot available, the patient device makes a selection of either the IMD orthe MP as the source of control, the selection being based on either apre-programmed format, on information obtained by the patient device atthe time that the decision is made, or both.

In the algorithm shown in FIG. 36, if the patient determines thattreatment is warranted and selects IMD management, the patient devicesignals the IMD to proceed with the IMD pre-programmed managementalgorithm. If the patient determines that treatment is warranted andselects the MP, the patient device and/or the IMD transmits informationto the MP sufficient to allow the MP to make a management decision. TheMP receives the information, and selects the therapy. The MP thentransmits the appropriate control signals to the IMD, allowing forexecution of the MP choice.

FIG. 37 shows an algorithm for management of a system with an IMD, apatient with a patient device, and an MP, in which the MP is given theoption of choosing which entity is in control, and in which signals areprimarily monitored at the patient device. If an abnormality is detectedwhich may require therapy, signals are transmitted to the MP at theremotely located remote station (“RS”), who makes a decision as towhether therapy is warranted, and if it is, as to which of the IMD, thepatient or the MP will be the source of control. The transmitted signalswill carry the aforementioned information from the patient device, andmay carry additional information from the IMD. The MP decision may bebased on a pre-selected format, or the medical professional in theremote station may make a selection based on information which thepatient device provides concerning the current condition (eitherphysiologic, cognitive or both) of the patient; or the MP decision maybe based on the MP experience and knowledge, as indicated in conjunctionwith the specification for FIG. 33. The MP may also make his/herdecision after consulting the M.E. device database.

In the algorithm shown in FIG. 37, if the MP determines that treatmentis warranted and selects IMD management, he/she signals the IMD toproceed with the IMD pre-programmed management algorithm. Supplementaryinformation obtained at the patient device may be provided to the IMD.If the MP determines that treatment is warranted and selects patientmanagement, then the patient is queried by the patient device todetermine availability. If the patient is available, the appropriateinformation is presented to the patient. The patient receives andreviews the information, selects a treatment via the patient device,which transmits control signals indicative of the choice of therapy tothe IMD. The IMD then executes the treatment ordered by the patient. Ifthe patient is unavailable, the MP then selects either the MP or the IMDas the source of control.

If the MP determines that treatment is warranted and self-selects, thenhe/she goes on to select the appropriate treatment, and then transmitsthe corresponding control signals to the IMD, allowing for execution ofthe MP choice.

In an algorithm analogous to that shown in FIG. 37 but not illustratedin a figure, the patient device could notify the medical expert device,instead of notifying the MP for decisions about whether treatment iswarranted and which entity is the treatment agent.

The figure showing such an algorithm would be similar to that of FIG.37, except that references to the MP would be replaced by references tothe M.E. device. In still other variations:

(a) The M.E. device could select a control agent from among the group:(i) IMD, (ii) patient, and (iii) MP (rather than M.E. device);

(b) The MP or M.E. device could select a control agent from among thegroup: (i) IMD, (ii) patient, (iii) M.E. device and (iv) MP; and

(c) Five (or more) agent control sharing arrangements are possible.

IMD system architectures are possible in which there is neither an MPnor a medical expert device, in which the only human source of controlis the patient, and in which the other sources of control are thepatient device, and the IMD itself. Management algorithm examples ofsuch three entity systems in which signal monitoring is primarily at theIMD are shown in FIGS. 38-40; and management algorithms in which signalmonitoring is primarily at the patient device are shown in FIGS. 41-43.

7.2 3-Entity Systems with IMD, Patient, and Patient Device

FIG. 38 shows an algorithm for management of a system with an IMD, apatient and patient device, in which the decision to consider treatingan abnormality takes place at the IMD. This algorithm is analogous tothe one shown in FIG. 29, since in both algorithms and figures, thechoice of whether treatment is warranted, and if it is, which of threeentities does the treating takes place at the IMD.

If an abnormality is detected at the IMD which requires therapy, the IMDand if the IMD selects IMD management, it proceeds with its ownpre-programmed management algorithm. If it determines that treatment iswarranted and selects patient management, then it queries the patient todetermine patient availability for management of the current event. Ifthe patient is available, the information is presented to the patient.The patient receives the information, selects a treatment via thepatient device, which transmits control signals indicative of the choiceto the IMD. The IMD then executes the treatment ordered by the patient.If the patient is unavailable, the IMD then selects either the patientdevice or the IMD as the source of control.

If the IMD determines that treatment is warranted and the patient deviceis selected, the IMD transmits information to the patient devicesufficient to allow the patient device to make a management decision.The patient device receives the information, and selects the therapy(including the possibility of selecting no therapy). The patient devicethen transmits the appropriate control signals to the IMD, allowing forexecution of the patient device choice.

FIG. 39 shows an algorithm for management of a system with an IMD, and apatient with patient device, in which the choice of controlling agentoccurs at the patient device. Signals are monitored primarily at theIMD. If an abnormality is detected which may require therapy, signalsare transmitted to the patient device, where a decision is made by thepatient device as to whether therapy is warranted, and if it is, as towhich of the IMD, the patient or the patient device will be the sourceof control.

In the algorithm shown in FIG. 39, if the patient device determines thattherapy is warranted and the patient device selects IMD management, itsignals the IMD to proceed with the IMD pre-programmed managementalgorithm. If the patient device determines that therapy is warrantedand the patient device selects patient management, then before therapycan proceed, it must be determined if the patient is available. Thepatient device queries the patient to determine availability. If thepatient is available, the information is presented to the patient. Thepatient receives the information, selects a treatment via the patientdevice, which transmits control signals indicative of the choice oftherapy to the IMD. The IMD then executes the treatment ordered by thepatient. If the patient is unavailable, the patient device then selectseither itself or the IMD as the source of control.

If therapy is warranted and the patient device is selected as the sourceof control, the patient device selects the therapy. It then transmitsthe appropriate control signals to the IMD, allowing for execution ofthe patient device choice.

FIG. 40 shows an algorithm for management of a system with an IMD, and apatient with patient device, in which the patient, if available, isgiven the options of deciding if therapy is warranted, and, if it is, ofmaking the choice of which entity is in control. Signals are monitoredprimarily at the IMD. If an abnormality is detected which may requiretherapy, signals are transmitted to the patient via the patient device,and then patient availability is determined. If the patient isavailable, a decision is made by the patient as to whether therapy iswarranted, and if it is, as to which of the IMD, the patient or thepatient device will be the source of control. Information available tothe patient includes the aforementioned IMD-based sensor and programminginformation, patient device-based sensor information, and the patient'sknowledge of how he/she is feeling, and his/her attitude about thevarious available therapeutic options. The patient reviews theinformation, and makes the aforementioned decision(s). If the patientdetermines that treatment is warranted and selects himself/herself asthe treatment agent, the patient selects their choice of therapy andindicates it via that patient device, which transmits control signalsindicative of the choice to the IMD. The IMD then executes the treatmentordered by the patient. If the patient is not available, the patientdevice or the IMD makes a selection of an alternate source of control,the selection being based on either a pre-programmed format, oninformation available at the time that the decision is made, or both.

In the algorithm shown in FIG. 40, if the patient determines thattreatment is warranted and selects IMD management, the patient devicesignals the IMD to proceed with the IMD pre-programmed managementalgorithm. If the patient determines that treatment is warranted andselects the patient device, the patient device analyzes the IMDinformation and selects the therapy. The patient device then transmitsthe appropriate control signals to the IMD, allowing for execution ofthe patient device choice.

FIG. 41 shows an algorithm for management of a system with an IMD, and apatient with patient device, in which the decision to consider treatingan abnormality takes place at the patient device. This algorithm isanalogous to the one shown in FIG. 34, since in both algorithms andfigures, monitoring takes place primarily at the patient device, but thechoice of which of three entities does the treating takes place at theIMD. A decision to consider treatment may occur at the patient devicerather than the IMD in a case where sensors inputting the patient deviceindicate a dire patient state, which may be undetected by the IMD.

If an abnormality is detected at the patient device which may requiretherapy, information about the patient device observation is transmittedto the IMD. At the IMD, a decision is made as to whether treatment iswarranted. The decision may be based on (a) the information transmittedby the patient device, (b) information derived from the IMD sensor(s),or (c) both (a) and (b). If the decision is to treat, the IMD makes adecision as to which of the IMD, the patient or the patient device willbe the source of control.

In the algorithm shown in FIG. 41, if the IMD determines that treatmentis warranted and selects IMD management, it proceeds with its ownpre-programmed management algorithm. If it determines that treatment iswarranted and selects patient management, then it queries the patient todetermine patient availability for management of the current event. Ifthe patient is available, the information is presented to the patient.The patient receives the information, selects a treatment via thepatient device, which transmits control signals indicative of the choiceto the IMD. The IMD then executes the treatment ordered by the patient.If the patient is unavailable, the IMD then selects either the patientdevice or the IMD as the source of control.

If the IMD determines that treatment is warranted and the patient deviceis selected, the IMD transmits information to the patient devicesufficient to allow the patient device to make a management decision.The patient device receives the information, and selects the therapy(including the possibility of selecting no therapy). The patient devicethen transmits the appropriate control signals to the IMD, allowing forexecution of the patient device choice.

FIG. 42 shows an algorithm for management of a system with an IMD, and apatient with patient device. Signals are monitored at the patientdevice. If an abnormality is detected which requires therapy, a decisionis made by the patient device as to which of the IMD, the patient or thepatient device will be the source of control. Additional information maybe requested from the IMD (as shown in FIG. 10).

In the algorithm shown in FIG. 42, if the patient device selects IMDmanagement, it sends signals to the IMD which allow the IMD to make atherapeutic decision. If the patient device selects patient management,then the patient device queries the patient to determine availability.If the patient is available, the information is presented to thepatient. The patient receives the information, selects a treatment viathe patient device, which transmits control signals indicative of thechoice of therapy to the IMD. The IMD then executes the treatmentordered by the patient. If the patient is unavailable, the patientdevice then selects either itself or the IMD as the source of control.If the patient device is selected it selects the therapy. It thentransmits the appropriate control signals to the IMD, allowing forexecution of the patient device choice.

FIG. 43 shows an algorithm for management of a system with an IMD, and apatient with patient device, in which the patient is given the option ofmaking the choices as to whether therapy is warranted, and, if it is, asto of which entity is in control. If an abnormality is detected whichmay require therapy, signals are transmitted to the patient via thepatient device, and then patient availability is determined. If thepatient is available, a decision is made by the patient as to whethertreatment is warranted, and if warranted, as to which of the IMD, thepatient or the patient device will be the source of control.

Information available to the patient and options for providing IMDinformation are similar to those indicated in the specification of FIG.36 hereinabove. The patient reviews the information, determines iftreatment is warranted, and if it is, selects a treatment agent via thepatient device. If the patient determines that treatment is warrantedand selects himself/herself as the treatment agent, the patient selectstheir choice of therapy and indicates it via that patient device, whichtransmits control signals indicative of the choice to the IMD. The IMDthen executes the treatment ordered by the patient. If the patient isnot available, the patient device or the IMD makes a selection of eitherthe IMD or the patient device as the source of control, the selectionbeing based on either a pre-programmed format, on information obtainedby the patient device and/or the IMD at the time that the decision ismade, or both.

In the algorithm shown in FIG. 43, if the patient determines thattreatment is warranted and selects IMD management, the patient devicesignals the IMD to proceed with the IMD pre-programmed managementalgorithm. If the patient determines that treatment is warranted andselects the patient device, the patient device selects the therapy. Itthen transmits the appropriate control signals to the IMD, allowing forexecution of the patient device choice.

7.3 Generalized 3-Entity Systems

In FIGS. 44 and 45, the term “entity” refers to any of the possiblechoices of monitoring or control agent, i.e. the IMD, the patientdevice, the patient, the medical expert device, or the MP. FIG. 44 showsa generalization of three entity control formats in which both primarymonitoring and the decision as to whether therapy is warranted takeplace at the same entity (which is arbitrarily designated as Entity #1).Furthermore, if therapy is warranted, the choice of which of the threeentities is the control agent takes place at the entity which does theprimary monitoring. The algorithm is structurally parallel to thoseshown in FIGS. 29, 35, 38 and 42, except that, besides the provisionsbeing made for the possibility that one of the entities is unavailable(which in the aforementioned specification was generally the patient),additional provisions are made for another of the entities beingunavailable (which may be, for example, the MP, if communications withthe MP are inadequate).

In the algorithm, Entity #1 determines if treatment is warranted, and,if it is, selects from among itself, Entity #2 and Entity #3 as thechoice of treatment agent. If either Entity #2 (or Entity #3) isselected and is unavailable, then Entity #1 selects between itself andEntity #3 (or Entity #2) as the control agent. If both Entity #2 andEntity #3 is unavailable, Entity #1 provides the control.

FIG. 45 shows a generalization of three entity control formats in whichprimary monitoring and the decision as to whether therapy is warrantedtake place at different entities, designated as Entity #1 and Entity #2,respectively. If Entity #2 is available, it determines if therapy iswarranted, and if it is, it selects from among itself, Entity #1 andEntity #3 as the choice of control agent. It is assumed that Entity #1is available, since the algorithm was initiated with a monitoring and atransmission event by Entity #1. If Entity #3 is selected by Entity #2but is unavailable, Entity #2 selects from among itself and Entity #1.

If Entity #2 is unavailable, system programming (e.g. by the ControlHierarchy programming screen shown in FIG. 14) will have predeterminedwhether Entity #1 or Entity #3 is dominant

(a) If Entity #1 is dominant, it determines if treatment is warranted,and if warranted selects between itself and Entity #3 as the controlagent. If Entity #3 is selected by Entity #1 but is unavailable, thenEntity #1—assumed to be available as indicated hereinabove—becomes thecontrol agent. The selected and available entity from among Entities #1and #3 then controls management.

(b) If Entity #3 is dominant, its availability is then determined. Ifavailable, it determines whether treatment is warranted, and thenselects from among itself and Entity #1 as the control agent. Theselected entity from among Entities #1 and #3 then controls management.

7.4 2-Entity Systems with IMD and Patient

FIGS. 46-49 illustrate algorithms for two-entity IMD systems in whicheither (a) the IMD decision making circuits or (b) the patient in whomthe IMD is implanted, control treatment administration by the IMD. Inorder for the patient to be able to interact with the IMD, there wouldbe a patient device, but—as is the case with the algorithms of FIGS. 29,31 and 33—the patient device is not one of the possible controlentities. In FIGS. 46 and 47, primary monitoring occurs at the IMD,while in FIGS. 48 and 49, primary monitoring is at the patient device.

In the algorithm shown in FIG. 46, if the IMD determines, based on itsmonitoring, that therapy is warranted, it next determines if the optimumapproach is management by the IMD treatment algorithm or by the patient.Certain ranges of treatment abnormality may best be suited to patientmanagement, and others to IMD management. These may be determined bypreprogrammed notification criteria (see FIGS. 71A-76C). If the IMD isselected, it functions as pre-programmed. If the patient is selected,patient availability is checked. If the patient is available, he/sheselects a treatment option and transmits the appropriate control signalto the IMD; If the patient is not available, the IMD is so informed, andit selects therapy.

In the algorithm shown in FIG. 47, if the IMD determines, based on itsmonitoring, that therapy may be warranted, it attempts to notify thepatient via the patient device. If the patient is available, the patientis presented with adequate information from the IMD to determine iftreatment is warranted and to make a choice between choice therapyselection by the IMD or by the patient. The patient may base thedecision on known general guidelines, on additional testing that thepatient may then perform, or on how the patient is then feeling. If thepatient self selects, he/she selects the therapy and signals the choiceto the IMD via the patient device. If the IMD is selected, the patientso notifies the IMD and it functions as pre-programmed. If the patientwas unavailable, the IMD is notifies and it selects the therapy.

In the algorithm shown in FIG. 48, if the patient device determines,based on its monitoring, that therapy may be warranted, it next transmitsignals to the IMD to inform it of the patient device data. Such datamay also include a request from the patient to initiate or consider theinitiation of therapy. At the IMD, a decision about whether therapy iswarranted is then made. Next a decision about the choice of controlentity—patient or IMD—is made. If the patient is selected, patientavailability is determined. If the patient is available, the patientselects therapy and cause the patient device to transmit the appropriatesignals informing the IMD of the selection. The IMD controls therapyselection if either (a) the patient is not available after beingselected or (b) IMD management was the choice of the IMD agent selectionprocess.

In the algorithm shown in FIG. 49, if the patient device determines,based on its monitoring, that therapy is warranted, it next attempts toalert the patient and assess patient availability. It the patient isavailable, the patient determines whether therapy is warranted, and ifit is, selects the control agent from among itself and the IMD. If thepatient selects the IMD, the patient device informs the IMD, after whichpre-programmed IMD management occurs. The pre-programmed management mayinclude one approach when the IMD is not signaled by the patient in thisway, and an alternate approach when it is signaled by the patient. Ifthe patient selects self-management, the patient makes a therapeuticchoice and signals the IMD of the choice via the patient device, afterwhich the IMD delivers the selected therapy.

7.5 5-Entity Systems with IMD, Patient Device, Patient, Medical ExpertDevice and Medical Professional

FIGS. 50-52 show algorithms for the management of a 5-entity IMD systemincluding: an IMD, a patient device, a patient, a medical expert device(as discussed hereinabove) and a medical professional. The three figuresare distinguished by the location at which (a) monitoring occurs and (b)the choice of agent to select therapy is made. In FIG. 50, the locationis the IMD. In FIG. 51, the location is the patient device. In FIG. 52the location is the remote station. In principle, 25 such figures may begenerated, i.e. 5sup(2), since there are five possible monitoringlocations and five possible locations at which to choose the agent whichselects therapy. When a monitoring location is not the location wheresignals carrying patient information originate, such signals (eitherun-analyzed or already analyzed) may be forwarded to the monitoringlocation as can be seen from FIG. 4. Furthermore, algorithms arepossible in which any of the 5 possible entities may be selected foreach of (a) the monitoring location, (b) the location for thedetermination of whether therapy is warranted, and (c) the location forthe determination of which entity selects therapy; Thus as many as 125algorithms, i.e. 5sup(3) are possible.

FIG. 50 shows primary monitoring at the IMD. If the IMD determines thattherapy is warranted, the IMD selects one of the five possible entitiesto become the control agent. If the patient is selected, a determinationis made as to whether the patient is available; If not, the IMD selectsan alternate source of control. If the IMD self-selects, it administersa pre-programmed therapy choice. If the IMD selects another agent, thenthat other agent receives the necessary information to make a choice oftherapy, that agent makes the choice, and transmits informationindicating the choice to the IMD. The situation in which one or more ofthe possible choices for control agent is not able to be communicatedwith is discussed hereinabove, and would result in an alternateselection for choice of controlling agent. If no other agents areavailable, the IMD would act autonomously.

FIG. 51 shows primary monitoring at the patient device. If the patientdevice determines that therapy is warranted, the patient device selectsone of the five possible entities to become the control agent. If thepatient is selected, a determination is made as to whether the patientis available; If not, the patient device selects an alternate source ofcontrol. If the patient device self-selects, it determines theappropriate control signal(s), and transmits them to the IMD. If thepatient device chooses the IMD as the control agent, the patient devicesso notifies the IMD, which then selects the appropriate therapy. If thepatient device selects a control agent other than itself or the IMD,then that other agent receives the necessary information to make achoice of therapy, that agent makes the choice, and transmitsinformation indicating the choice to the IMD. The situation in which oneor more of the possible choices for control agent is not able to becommunicated with has been discussed hereinabove.

FIG. 52 shows primary monitoring at the remote station. This wouldentail the transmission of at least one of (a) IMD information, and (b)patient device information, to the remote station. In the case of both(a) and (b), the remote station may amalgamate the informationtransmitted from each of the IMD and the patient device. Alternatively,such amalgamation may take place at either the IMD (by transmission ofpatient device information from the patient device to the IMD, as shownin FIGS. 10 and 11), or at the patient device (by transmission of IMDinformation from the IMD device to the patient device, as shown in FIGS.8 and 9), and be followed by transmission of the amalgamated informationto the remote station.

At the remote station, a determination is then made, as to whethertherapy is warranted. If therapy is warranted, the remote stationselects one of the five possible entities to become the control agent.If the patient is selected, a determination is made as to whether thepatient is available; If not, the remote station selects an alternatesource of control. If the IMD is selected, it administers apre-programmed therapy choice. If the remote station selects anotheragent, then that other agent receives the necessary information to makea choice of therapy, that agent makes the choice, and transmitsinformation indicating the choice to the IMD. The situation in which oneor more of the possible choices for control agent is not able to becommunicated with is discussed hereinabove, and would result in analternate selection for choice of controlling agent. If no other agentsare available, the IMD would act autonomously.

A single remote station may house both the MP and the medical expertdevice, or the MP and the M.E. device may each be situated in separateremote stations. In either case, the MP and M.E. device may be incommunication, as indicated by FIG. 4 herein and by FIG. 2C of U.S.patent application Ser. No. 12/154,079.

7.6 Alternate 3-Entity System with IMD, Patient and Medical Professional

FIG. 53 shows an IMD system control algorithm which differs in formatfrom those algorithms shown in FIGS. 29-52. Whereas the algorithms inFIGS. 29-52 are analogous to those in FIGS. 6C and 6D of U.S. patentapplication Ser. No. 12/154,079, the algorithm shown in FIG. 53 isanalogous to that shown in FIG. 6A of Ser. No. 12/154,079, in which theIMD functions autonomously unless it is inhibited and/or induced toapply therapy by a remotely originating signal.

Rather than remotely transmit all IMD data—which would impose a majorIMD battery drain—a notification signal is transmitted to a medicalprofessional if notification criteria for the MP are met, and to thepatient, if notification criteria for the patient are met. Thenotification criteria for the MP and for the patient may not be thesame, and each of the two notification criteria may differ from thetreatment criteria for the IMD (as discussed in conjunction with FIGS.71A-76C).

If either one of the MP or the patient is notified, they have theoption, after reviewing data pertaining to the event which triggeredsuch notification, of causing or changing treatment by the IMD. Ifeither of them decides to do so, they select and transmit appropriatecommands, whether inhibitory, or causative of treatment. The commandsare decrypted, decoded and enacted by the IMD, after which it sends aconfirmation signal to the person who was the source of the command(s).If both the MP and the patient are notified, they may (a) work out atreatment plan together, after which one of them sends the appropriatecontrol signal(s) to the IMD; (b) negotiate which of the two is to bethe controlling entity, after which the controlling entity selects andtransmits IMD instructions; (c) agree that IMD control is the bestoption.

Versions of FIG. 53 in which other non-IMD entities other than the MPand the patient have the opportunity to alter IMD treatment after theyare notified are possible. If there are two or more such entities, thenthere must be a negotiation or transaction in which the possiblecontrolling entities agree on treatment or agree on the selection oftreating entity.

7.7 Second Alternate 3-Entity System with IMD, Patient and MedicalProfessional

FIGS. 54 through 56B show four algorithms in which there is neither (a)the negotiation or transaction discussed in conjunction with FIG. 53,nor (b) an overarching selection by one entity at the time of a patientevent, as to choice of control agent, as in FIGS. 29-52. Instead, asshown in FIGS. 54-56B, a preprogrammed, control hierarchy isestablished, in which:

(a) each possible control entity is ranked;

(b) the highest ranked control entity may control the IMD if

-   -   (i) it is notified, and    -   (ii) it chooses to exert such control;

(c) another entity may control the IMD, if all possible control entitieswhich are more highly ranked do not exert such control; and

(d) the lowest ranked entity controls the IMD, if none of the otherpossible control entities exert such control.

These figures are analogous to FIG. 6B of U.S. patent application Ser.No. 12/154,079, which shows a conceptually similar algorithm for a twoentity system consisting of the IMD and the MP.

In one embodiment of the invention, such a control hierarchy isestablished only once, (a) at the time that the IMD is implanted, (b)before it is implanted, or (c) at a time later than the implant. Inanother embodiment of the invention, the hierarchy may be altered on oneor more occasions. FIG. 14 shows a programming screen which sets up oralters such a hierarchy, and FIGS. 13 and 15 show programming screenswhich allow (or do not allow) access to such programming.

FIG. 54 shows an algorithm in which control of the IMD may be sharedamong three entities: (1) the IMD therapy decision-making elements, (2)the patient (via a patient device) and (3) the medical professional (viaa remote station). The control hierarchy (for the example shown in thefigure) is such that the MP is placed most highly, the patient next andthe IMD lowest. Thus the patient, if notified, may overrule the IMD, andthe MP, if notified, may overrule either the patient or the IMD. Sincenotification criteria are programmable, and since even the hierarchy isprogrammable (though such programming would result in a differentalgorithm than that shown in FIG. 54), there is a very large amount ofpotential flexibility in the control of the IMD.

Analysis of sensor signals at the IMD may lead to one or more of: (a)IMD treatment criteria met (b) patient notification [and receipt of IMDdata] if patient notification criteria are met, and (c) MP notification[and receipt of IMD data] if MP notification criteria are met. Aparticular patient condition may trigger none, any one, any two or allthree of (a), (b) and (c). Notification of either the MP or the patientis considered to be an invitation to control treatment, which may or maynot be accepted by the receiving entity. Thus if the MP is notified andthe MP decides to control treatment, then he/she analyzes the receiveddata, decides on appropriate therapy, transmits it to the IMD; The IMDdecrypts and decodes the information, enacts the transmitted commands,and sends a confirmation signal to the MP. The MP may optionallyreprogram the IMD after such notification.

If the MP was either not notified, or chose not to react to thenotification, then the patient—if notified—has the opportunity toinitiate therapy in a sequence similar to that of the MP: The patientanalyzes the received data, decides if therapy is warranted and, if so,decides on appropriate therapy. Using a patient device which convertsthe patient selected choices into IMD command signals, the patient thencontrols the IMD; The IMD decrypts and decodes patient command signalsand delivers therapy and sends a confirmation signal to the patient. Thepatient may optionally reprogram the IMD after such notification.

If neither the MP nor the patient intervenes with a command signal,then, as shown in the figure, the IMD therapy which is programmed forthe particular conditions that currently obtain is applied, and anoptional confirmation signal may be sent to either the patient, the MPor both.

In a simple example, if the notification criteria for each of the MP andthe patient are the same as the treatment criteria of the device, thenwhen those criteria are met both the MP and the patient will be notifiedand have the opportunity to intervene. The MP gets the highest priority.If the MP declines, the patient has the opportunity to control the IMD.If both the MP and the patient decline, the IMD performs based on itspreprogrammed treatment algorithm.

The flow diagram includes the possibility that MP or patientnotification was programmed for a medical state for which no IMD therapyis programmed. An example is the case of a the management of relativelyslow tachycardia:

-   -   IMD is an ICD    -   Treatment Criteria: Rate greater than 120 b.p.m.    -   Patient Notification Criteria: Rate greater than 120 b.p.m.    -   MP Notification Criteria: Rate greater than 135 b.p.m.    -   ICD Programming: Automatically treat tachycardia with rate >150        b.p.m.        In the case of a tachycardia with rate 130 b.p.m.:

(a) The MP is not notified because the rate is less than 135 b.p.m.

(b) The patient is notified, feels no symptoms, is exercising, andreasonably concludes that the tachycardia requires no treatment.

(c) The ICD does not treat because its rate cutoff (for automatictreatment) is 150 b.p.m.

A more complex example involving an ICD:

-   -   Treatment Criteria: Tachycardia with rate > or =140 b.p.m. for        10 seconds    -   Patient Notification Criteria: Tachycardia with rate between 140        and 160 b.p.m. for 10 seconds    -   MP Notification Criteria: Tachycardia with rate greater than 340        b.p.m. for 1.5 seconds.    -   ICD Programming: Tachycardia detection for rate >160 b.p.m.        This particular algorithm would operate as follows:

For tachycardia with rate between 140 and 160 beats per minute for 10 ormore seconds, the patient is offered the opportunity to dictatetreatment. The patient could choose to inhibit therapy (e.g. if he/shefelt perfectly fine and had good reason to believe that the heart rateelevation was due to sinus tachycardia). The patient could also choose anon-aggressive therapy, rather than a more aggressive treatment whichmight be programmed for the ICD response. If the patient does notintervene, the ICD delivers pre-programmed therapy.

For tachycardia with rate greater than 160 b.p.m. and up to 340 b.p.m.,neither the patient nor the MP is notified, and the ICD operatesautonomously.

For tachycardia with a rate greater than 340 b.p.m. and lasting 1.5 ormore seconds, the MP is notified. The MP has priority over the ICD. TheMP may issue a command to inhibit therapy if the MP believes that thehigh rate signals are due to the malfunction of either the defibrillatorlead, the defibrillator, the interface between the lead and thedefibrillator, or that the high rate signals are due to electromagneticinterference. Such a command serves the purposes of (a) potentiallyavoiding the delivery of an inappropriate ICD shock, and (b) potentiallyavoiding a series of capacitor charges and dumps, if the period ofobserved high rate is not long enough to trigger shock delivery but islong enough to trigger the start of capacitor charging. If the MPbelieves that there is a significant chance that the observed high ratesignal represents a very fast tachycardia, the MP may allow the ICD toproceed with treatment, or the MP may initiate treatmenthimself/herself.

Many other complex patterns of programming are possible and will beobvious to those skilled in the art. Such patterns are further discussedin conjunction with FIGS. 71A to 76C and 78 to 82.

FIG. 55 shows an algorithm that is morphologically similar to that ofFIG. 54. However, in the FIG. 55 algorithm, the hierarchical positionsof the MP and the patient are switched with respect to that shown inFIG. 54; In FIG. 55, the patient occupies the highest position in thecontrol hierarchy, the MP occupies the intermediate position and the IMDoccupies the lowest position. Thus, in the FIG. 55 algorithm, the MP mayoverrule the IMD, and the patient may overrule both the IMD and the MP.

7.8 Alternate 5-Entity System with IMD, Patient Device, Patient, MedicalExpert Device and Medical Professional

FIG. 56A shows a five-entity version of the algorithms shown in FIGS. 54and 55. The hierarchical sequence, from highest to lowest is: MP,medical expert device (“M.E.D.” in the figure, and “M.E. device” inother figures), patient, patient device (“PT.D.” in the figure, and “PTdevice” and “PTdev” in other figures) and the IMD. Thus, for example,the IMD may overrule no other entity, and the MP may overrule all otherentities.

The algorithm shown in FIG. 56B is similar to that of FIG. 56A exceptthat the FIG. 56B algorithm also shows the operational aspects of theprogramming of control hierarchy. In order for any entity toparticipate, their response must be enabled. Such enabling would be theresult of programming of control hierarchy, and such programming isillustrated by the control screen shown in FIG. 14.

Referring again to FIG. 56B, in order for the MP to have the option tointervene in therapy, the MP response must have been enabled. The sameis true for each of the M.E. device, the patient and the patient device.In an exemplary circumstance in which neither the M.E. device nor thepatient device are enabled, the algorithm shown by FIG. 56B willfunction in a manner similar to that of FIG. 54. In FIG. 14, theprogramming of such an algorithm would be accomplished as is seen in thesecond row of items, beginning with “conditions B1, B2, B3 and B4”[which could be, in the case of an ICD, related to one or more of (a)heart rate, (b) sudden onset, (c) interval stability and (d)morphology], and including a control hierarchy in which the IMD is atthe lowest level, the patient at an intermediate level and the MP at thehighest level.

In a further exemplary circumstance in which none of (a) the M.E.device, (b) the patient response, and (c) the patient device control areenabled, the algorithm shown by FIG. 56B will function in a mannersimilar to that of FIG. 6B of U.S. patent application Ser. No.12/154,079. In FIG. 14, the programming of this algorithm would beaccomplished as is seen in the first row of items, beginning with“conditions A1, A2, and A3”, and including a control hierarchy in whichthe IMD is at the lower level, and the MP at the higher level.

One IMD may be programmed to have different control hierarchies fordifferent medical states. For example, a single ICD, at one time, withan operating algorithm consistent with that shown in FIG. 56B, could beprogrammed:

-   -   (a) to have the control hierarchy indicated by row 1 of FIG. 14        (with MP dominant over IMD) for conditions labeled A1, A2 and        A3;    -   (b) to have the control hierarchy indicated by row 2 of FIG. 14        (with MP dominant over patient, and patient dominant over IMD)        for conditions labeled B1, B2 B3, and B4; and    -   (c) to have the control hierarchy indicated by row 5 of FIG. 14        (with MP the only source of control) for conditions labeled E1,        and E2.

Just as FIG. 55 is a variation of FIG. 54, in the sense that it shows analteration in the sequence of control hierarchy (The MP dominates overpatient in FIG. 54 and the patient dominates over the MP in FIG. 55.),many such alterations are possible with a five-entity format. There are5 factorial, or 120 possible algorithms. Thus the programming of thealgorithm for line 3 of the screen shown in FIG. 14 would result in aflow diagram similar to that shown in FIG. 56B; To construct such afigure, one starts with the diagram shown FIG. 56B and switches thelabels for “PT” (patient) with the labels for “PT.D.” (patient device).The result is a flow diagram in which:

(a) the IMD is the default control entity;

(b) the patient may overrule or preempt the IMD;

(c) the patient device may overrule or preempt each of (i) the patientand (ii) the IMD,

(d) the medical expert device may overrule or preempt each of the (i)the patient device, (ii) the patient and (iii) the IMD;

(e) the medical professional may overrule or preempt each of the (i) themedical expert device, (ii) the patient device, (iii) the patient and(iv) the IMD.

FIG. 56C shows a generalized version of FIG. 56B. This figureaccommodates any possible relationship between an MP, a patient, apatient device, a medical expert device and an IMD. It could apply to adifferent list of control sources (e.g. multiple different caregivers).It could also apply to any kind of PMD, i.e. a purely internal device, apurely external device or a hybrid device. “Other Options A” refers to asituation in which none of the entity responses is enabled. This mightbe the case for a device which is at end of service, or a device whichis incompatible with a particular patient. Such options include noaction, and include notification of an appropriate person. “OtherOptions B” refers to a situation in which none of the authorized devicecontrollers responds. Such non-response may be clinically appropriate,in which case no action may be appropriate. Alternatively,re-notification of any of the entities, or a more aggressive form ofnotification are options.

FIG. 56D carries the generalization of FIG. 56C one step further, byindicating that any number of control sources is possible.

7.9 Blending of Two or More Analysis/Control Algorithms

As indicated hereinabove in FIG. 7A, and also in FIGS. 1, 7B, 8, 13,27A, 27B, and hereinbelow in FIGS. 77 and 82, and in the specificationassociated with each of the aforementioned, there are embodiments of theinvention in which the IMD has a plurality of algorithms, each of whichindependently analyzes and/or assesses the need for treatment and/orselects the appropriate treatment. In such embodiments, a need exists todetermine a choice, if the algorithms do not agree with each other, interms of analysis or treatment recommendation. Hereinbelow, with respectto the specification of FIGS. 57 and 58, the output of each of the threealgorithms (and of the master algorithm) is generally referred to as atreatment recommendation, but the process shown in the figures isequally applicable to dealing with non-identical event analyses by thethree algorithms (see, for example, FIG. 82). FIG. 57 shows a masteralgorithm to be used for selecting the treatment to be implemented fromamong the outputs of three algorithms which operate in parallel. FIG. 58shows a master algorithm for dealing with IMDs with two parallelalgorithms; the FIG. 58 algorithm may also operate with a threealgorithm device, when combined with the FIG. 57 algorithm.

Referring to FIG. 57, each of the three IMD algorithms analyzes sensordata and produces a management decision (or an analysis). If the threedecisions (or analyses) are identical, then this uniform decision isimplemented. It the three are not identical, then options includecontacting the MP, contacting the patient, or further analysis prior tofinal assessment.

With respect to FIGS. 57 and 58, the choice of which option is selectedfrom a multiplicity of options, will generally be preprogrammed; Thispre-programming may be simple (e.g. if two out of three of thealgorithms agree, select their choice; and if not, refer to thepatient), or it may be more complex, and depend on the urgency of thesituation, details of the situation, the availability of the patient andother factors). The same is true of each of the multi-option branches inthe algorithms in FIGS. 57 and 58.

If contacting the patient or MP is selected, the IMD proceeds asindicated hereinabove. As shown in FIG. 8, the IMD may transmit:

(a) the analysis of one or more of algorithms #1, #2 and #3;

(b) “raw,” i.e. unprocessed or minimally processed sensor data;

(c) the results of a blending or an averaging process (see hereinbelow)in which the master algorithm attempts to combine two or morenon-identical recommendations; and/or

(d) the final decision of the master algorithm.

If proceeding with the algorithm is selected, it queries whether two ofthe three IMD algorithm decisions are identical. If yes, the options are(a) to select that majority decision, or (b) to notify the patient orMP). Alternatively, if the disagreement among the algorithms does notinvolve a yes/no decision or a choice among different therapies, butdoes involve a numerical choice (e.g. the dose of a drug to beadministered, or the selection of a rate of stimulation or an intensityof stimulation), an “averaging” process may be used (see hereinbelow),in which all three recommendations contribute. If two of three IMDalgorithm decisions are not identical, then the options include (a)further analysis, or (b) contacting the patient or MP. If furtheranalysis is chosen, then the algorithm queries whether any two of thethree decisions are nearly identical. If they are not, the optionsinclude (a) contacting the patient or MP, and (b) an “averaging”process.

The averaging process may be a strict average; For example, ifantitachycardia pacing at 180 b.p.m. is the recommendation of algorithm#1, and ATP at 195 b.p.m. is the recommendation of algorithm #2, and ATPat 225 b.p.m. is the recommendation of algorithm #3, then the numericalaverage of the three, 200 b.p.m. might be selected. Alternatively, (a)the middle value may be selected, or (b) there may be a process by whicheach of the three recommendations is assigned a weight, and a weightedaverage is performed. The weight may, for example, depend on the pastperformance of each algorithm. In yet another approach, the average ofthe two closest values (in the aforementioned example: 180 and 195b.p.m.) may be selected (discussed hereinbelow). Hereinabove andhereinbelow, the term “average”, when used with quotation marks, isintended to indicate all of the above averaging options.

If two of the algorithm decisions are nearly identical, the masteralgorithm queries whether all three are nearly identical. If not thenthe options include:

(a) selecting one of the two closest decisions (if a determination of“closeness” is applicable [i.e. if the decisions are qualitatively thesame, but quantitatively different); The method of selection will bepreprogrammed (e.g. [i] always select the most aggressive decision, [ii]always select the least aggressive decision, [iii] make the decisionbased on prevailing conditions, etc.);

(b) selecting an “average” of the two closest (as defined hereinabove)decisions; and

(c) contacting either the MP or the patient.

If all three of the IMD algorithm decisions are nearly identical, thenthe options include each of the three choices (a)-(c) immediatelyhereinabove, and (d) performing and selecting the “average” of all threeIMD algorithm recommendations.

FIG. 58 shows a master algorithm for the management of IMDs which runtwo parallel analysis and/or treatment selecting algorithms; Thealgorithm shown in FIG. 58 may also be used for a three-algorithmdevice. If the analysis and/or management recommendation of each of thetwo algorithms is identical, then that recommendation is implemented(referred to in the figure as that of algorithm #1, which in this caseis identical to algorithm #2). If the decisions are not identical, thenthe master algorithm queries whether the decision involves a yes/nodecision (or other decision with choices not amenable to an “averaging”process). If the format is yes/no, then options include (a) notifyingthe patient or MP, and thereby requesting their input; and (b) if theIMD has a third algorithm, checking for the recommendation of that thirdalgorithm, and then proceeding from the denoted entry point to themaster algorithm shown in FIG. 57. Alternatively (not shown in thefigure for this branch of the algorithm), a decision to select one ofthe choices of algorithm #1 or algorithm #2 may be made (based onpreprogrammed decision criteria, as indicated hereinabove).

If the decision format is not a yes/no issue, but rather involvessimilar aspects which differ by a numeric parameter, then the algorithmqueries whether the two IMD recommendations are nearly identical. Ifthey are not, then the options are identical to those immediatelyhereinabove for the situation in which there is a yes/no format.However, if the two recommendations are nearly identical, then theoption list, besides including each of the options immediatelyhereinabove for the yes/no format (including selecting one of algorithm#1 or algorithm #2), the additional option of implementing the “average”of algorithm analysis/recommendation #1 and of algorithmanalysis/recommendation #2 is available.

The analysis/management concepts discussed hereinabove with regard toFIGS. 57 and 58 may be generalized to IMD systems with four or morealgorithms. With larger numbers of algorithms, there will be morelatitude in terms of using statistical measures and means known in theart, when the analyses and/or recommendations do not agree.

The step in the algorithm shown in FIG. 58 which calls for the inclusionof a third algorithm, after two algorithms produce non-identical resultsmay use an algorithm that is outside of the IMD, i.e. an algorithm whichruns in either:

(a) the patient device,

(b) the M.E. device, or

(c) another IMD.

Alternatively, the opinion of the patient (or even the MP) may beutilized as the third algorithm output.

The most general statement about the inputs to each of FIGS. 57 and 58,is that any of the algorithm inputs may represent either a device or aperson. For example, the three algorithm inputs to the master algorithmof FIG. 57 could be:

(a) the IMD,

(b) an algorithm which runs on the patient device, and

(c) the opinion of the patient.

7.10 Control Handoff Algorithms

Hysteresis in a treatment algorithm allows for the conditions whichtrigger the transition from a first to a second treatment state todiffer from the conditions which trigger the transition back to thefirst treatment state from the second treatment state. For example, if:

the first treatment state is the absence of ventricular demand pacing at60 b.p.m.,

the second treatment state is the presence of ventricular demand pacingat 60 b.p.m.,

the conditions which trigger the transition from the first treatmentstate to the second treatment state are the heart rate falling below 50b.p.m., and

the conditions which trigger the transition from the second treatmentstate to the first treatment state are the heart rate rising above 60b.p.m.;

Then a patient with a pacemaker so programmed will begin pacing (at 60b.p.m.) when his/her heart rate falls below 50 b.p.m., and continue topace until the heart rate rises above 60 b.p.m.

The term hysteresis, in the case of the IMD system, refers to asymmetricconditions for (i) on the one hand, the transition from one of theentities (e.g. the IMD) being in control, to another entity (e.g. thepatient device) being in control, and (ii) on the other hand, thereverse transition.

7.10.1 Takeover and Return of Control

For example: FIG. 59 shows a flow diagram for the sharing of control ofan implanted blood sugar control device between (i) the implanted devicelogic circuits, and (ii) a patient-carried device logic circuits, whichmay additionally have input from the patient. The implanted deviceinitially monitors the blood sugar, and continues to do so, unless theblood sugar concentration fall below 40 mg./dl.; in which case atakeover of control by the patient device occurs. The patient device mayat that point do a better job of controlling the blood sugar (i) becauseof a better algorithm, (ii) because of access to external patientsensors, and/or (iii) because the patient may be allowed access toinsulin does decision making. In the algorithm shown in the figure, thepatient device remains in control until the blood sugar rises to a valueconsiderably better than the one at which the transition took place fromimplanted device-based control to patient device-based control.

This type of hysteresis format may apply to:

(a) other types of device systems, e.g. an ICD; and

(b) the act of taking and returning control by other devices within anIMD system, e.g. the M.E. device.

Furthermore, it can also apply to taking (and returning) control from(and to) a human (e.g. the patient), as well as from (and to) anotherdevice. It can also apply to transitions caused by humans (i.e. thepatient or the MP), though human decision making will not generally byabsolutely locked in to simple algorithmic formats.

FIG. 60 illustrates a generalized algorithm for enacting control similarto that shown in FIG. 59. Takeover of control (“takeover”) occurs whenthe value of a parameter or of Function* (as defined and discussed inconjunction with FIG. 22A-24) becomes sufficiently abnormal, but returnof control to the entity from which it was taken does not occur untilthe value of the parameter or of Function* becomes incrementally morenormal (“considerable better”, as stated in the figure) than was thecase at the time of the initial takeover. (Herein, “incrementally morenormal” and “considerably better” mean that the value returns not justto the cutoff point for the takeover transition, but to a more normalvalue than the takeover point—as was exemplified in the description ofFIG. 59.)

FIG. 61 illustrates a hysteresis scenario in which the criterion whichdistinguishes takeover from return of control is the duration of anabnormality—in this case, the duration of an abnormal heart rate. In thefigure, takeover occurs for a heart rate above 200 b.p.m. for a durationof 25 consecutive seconds. Return of control (e.g. from the M.E. deviceto the IMD) occurs if heart rate falls below 200 for 90 consecutiveseconds.

It may be desirable to have a format in which the conditions whichtrigger a takeover depend on two different parameter or Function*values; This situation is shown in FIG. 62. In order for takeover tooccur, both (i) the value of parameter #1 or Function* #1 and (ii) thevalue of parameter #2 or Function* #2 must be abnormal. Once takeoveroccurs, in order to restore the initial source of control, there must bea normalization of the values of both parameters or Function*s to adegree such that they both are incrementally more normal than was theirvalue at the time of the initial takeover.

If, after the sequence of takeover of control followed by return ofcontrol, the patient condition again becomes such that control by theprimary device may be considered to be suboptimal, a second takeover maybe desirable. Furthermore, if the timing of the second deterioration inpatient condition is such that it is in close temporal proximity to thefirst deterioration, it may be desirable to make the conditions for asecond takeover less extreme than those which precipitated the firsttakeover, i.e. to institute a method of heightened patient surveillanceafter the first takeover. Hereinbelow, the term “first takeover” is usedto refer to the first such takeover, and “second takeover” to refer tothe second such takeover.

7.10.2 Takeover #2

FIG. 63 shows an example of second takeover criterion differing fromfirst takeover criterion. In the example, first takeover (from the IMD,for example) occurs when the patient's blood sugar falls below 40mg./dl. Return of control occurs when the blood sugar rises to 70mg./dl. Second takeover occurs if the blood sugar falls to 50 mg./dl.(rather than 40 mg./dl., as was the cutoff for first takeover).

FIG. 64 shows an example in which the criteria for first and secondtakeover differ in two ways: (a) number of ICD shocks, and (b) width ofmoving window in time in which the cutoff number of shocks must occur.In the algorithm shown in the figure, the occurrence of three ICD shockswithin 10 minutes triggers a takeover of the IMD by an external device(either the patient device [with or without input from the patient], orthe medical expert device). Return of control to the ICD occurs if a twohour period elapses without a shock having been delivered to thepatient. However, as shown in the figure, following such a sequence, thecriteria for takeover are changed to two shocks within a 25 minuteperiod. The altered takeover criteria (i.e those for the secondtakeover) may (i) persist indefinitely, (ii) persist until the MP orother system entity resets the initial (or other) criteria, or (iii)transition gradually back to the first takeover criteria in apre-programmed manner over time, as shown hereinbelow in conjunctionwith FIG. 69.

FIG. 65 shows an algorithm which is a generalization of the process ofsecond takeover. First takeover is triggered by a specific abnormalityof a parameter or of Function*. Return of control is triggered by animprovement to a value of the parameter of Function* which isincrementally better than that which triggered the first takeover.Second takeover is triggered by a later occurring value of the parameteror Function* which is not as abnormal as that which triggered the firsttakeover.

Alternative second takeover formats are possible. The value of theparameter or Function* which triggers second takeover need not be moreabnormal than the value which triggered return of control. For example,with the blood sugar management system considered in FIG. 63, secondtakeover could occur when the blood sugar falls below 70 mg./dl. Instill other formats, the parameter of Function* value which triggerssecond takeover may be:

(a) the same as the one which triggers first takeover (a trivial case);and

(b) more abnormal than the one which triggers first takeover (e.g. bloodsugar less than 35 mg./dl. in FIG. 63 example); This would constitutedthe opposite of heightened surveillance, i.e. it would constitutediminished surveillance (perhaps an acknowledgement of a “brittle”management situation in a diabetic patient).

7.10.3 Return of Control #2

Just as the conditions for second takeover may differ from those offirst takeover, the criteria for return of control after a secondtakeover (i.e. the “second return of control”) may differ from thosewhich trigger return of control after the first takeover (i.e. the“first return of control”). FIG. 66 shows an example of an algorithmwhich illustrates this approach. In a patient with an implantable bloodsugar stabilization device, first takeover by an external device (e.g.the patient device) occurs when the blood sugar falls below 40 mg./dl.First return of control occurs when conditions improve to the extentthat the blood sugar rises to 70 mg./dl. Second takeover occurs when theblood sugar falls below 50 mg./dl. As indicated in the figure, there area variety of second return of control options including:

(a) second return of control not allowed;

(b) second return of control for blood sugar 70 mg./dl. or above (i.e.the same criteria as for first return of control); or

(c) second return of control for blood sugar 80 mg./dl. or above (i.e.more restrictive [i.e. more normal] criteria than for first return ofcontrol).

Many other second return of control criteria for a blood sugarmanagement system are possible and will be obvious to those skilled inthe art.

FIG. 67 shows an algorithm which illustrates a generalization of secondreturn of control. First takeover is triggered by a severe abnormality.(The words of “severe” or “severely abnormal” herein, hereinabove andhereinbelow may be considered to be a relative terms, chosen so thatthey might easily, semi-quantitatively be compared with otherdescriptors such as “non-severe”, “moderately abnormal”, “mildlyabnormal”, etc.) First return of control is triggered when the value ofthe parameter or Function* which refers to the abnormality improves to amildly abnormal value, i.e. a value which is incrementally better thanthat which triggered first takeover. Second takeover then may occur whenthe value of the parameter or Function* becomes moderately abnormal,i.e. more abnormal than the value which triggered first return ofcontrol, and less abnormal than the value which triggered firsttakeover. Second return of control:

(a) may not be allowed;

(b) may be triggered by an improvement in the parameter value orFunction* value to:

-   -   (i) a mildly abnormal value (i.e. the same value as the one        which triggered first return of control, or it may be triggered        by an even better value);    -   (ii) a normal value;    -   (iii) a value which is minimally better than the one which        triggered second takeover; or    -   (iv) other values.

Other second return of control scenarios are associated with each of thealternate second takeover formats hereinabove. For example:

(a) second takeover and first takeover criteria may be identical (e.g.blood sugar of 40 mg./dl.), but second return of control may be moredemanding than first return of control (e.g. blood sugar of 80 mg./dl.And 70 mg./dl., respectively.); and

(b) first takeover and first return of control are triggered byidentical parameter or Function* values (e.g. blood sugar values of 40mg./dl.), i.e. no hysteresis for first cycle; but second return ofcontrol requires a parameter or Function* value which is incrementallyless abnormal than the value which triggered second takeover (e.g. bloodsugar values of 50 mg./dl. for second takeover and 60 mg./dl. for secondreturn of control), i.e. hysteresis in effect for second cycle.

Still other second return of control criteria for IMD systems arepossible (for the general and for the specific cases) and will beobvious to those skilled in the art. In addition, systems are possiblein which third (and higher order) takeover criteria, and third (andhigher order) return of control criteria are programmable, using thesame principles as have been detailed herein.

A control screen for the programming of each of (a) takeover criteria,(b) return of control criteria, (c) second takeover criteria, and (d)second return of control criteria is shown in FIG. 13. The screen showsthat each of the IMD, the patient device and the medical expert devicemay be programmed accordingly. Each would be programmed with criteriawhich were not identical to another device in the IMD system.

7.10.4 Time Dependent Formats

Each of the control shifts after a takeover [(a) first return ofcontrol, (b) second takeover, and (c) second return of control, etc.]may be programmed in a time-dependent manner. That is, if an unstable orundesirable patient situation resulted or may have resulted frominadequate or suboptimal control by one of the devices in the IMD systemleading to a first or second takeover, then the duration of time that ittakes to rectify that unstable or undesirable state may influence thecriteria which determine the whether a reversal of the takeover ispermitted. Similarly, following a return of control, the duration of theperiod of stability may influence the criteria for a second takeover.

An example is shown by the algorithm in FIG. 68. The conceptual startingpoint for the figure is FIG. 61, in which takeover occurs after a heartrate of greater than 200 b.p.m for 25 consecutive seconds and return ofcontrol occurs after a heart rate of less than or equal to 200 b.p.m.for 90 seconds. The FIG. 68 algorithm indicates that if the heart rateof greater than 200 b.p.m. persists for 5 or more minutes, then a morestrict criterion, i.e. a heart rate of less than or equal to 185 b.p.m.for 90 consecutive seconds is required for return of control. Theunderlying concept is that greater patient stability (the rate less than185 b.p.m., as opposed to 200 b.p.m.) is required before return ofcontrol to the entity whose management resulted in or allowed thecurrent persistent tachycardia. Furthermore, as shown in the figure:

(a) If return of control has not occurred within 10 minutes after thestart of takeover, then a further degree of improvement (in this case,the rate falling to less than or equal to 170 b.p.m. for 90 consecutiveseconds) is required to trigger return of control; and

(b) If return of control has not occurred within 15 minutes after thestart of takeover, then a still further degree of improvement (in thiscase, the rate falling to less than or equal to 155 b.p.m. for 90consecutive seconds) is required to trigger return of control.

If return of control has not occurred within 20 minutes after the startof takeover, then a still further degree of improvement (in this case,the rate falling to less than or equal to 140 b.p.m. for 90 consecutiveseconds) is required to trigger return of control.

FIG. 69 shows an example of time-dependent takeover #2. The conceptualstarting point for this figure is FIG. 64, in which first takeover istriggered by 3 shocks within 10 minutes and, after return of control(triggered by no shock for a two hour period), second takeover istriggered by 2 shocks within a 25 minute moving window of time. Thiscreates a state of heightened surveillance after the multiple shocksituation. In the time-dependent algorithm of FIG. 69, the 2 shock per25 minute criterion gradually (in four steps over 72 hours) returns to 3shocks per 10 minutes. The approach is based on the concept that as timeelapses after the storm of shocks, a gradual return to the baselinetakeover criteria is desirable. As shown in FIG. 69:

(a) during the period up to 3 hours after return of control, takeover #2is triggered by 2 shocks in 25 minutes;

(b) during the period from 3 hours and up to 12 hours after return ofcontrol, takeover #2 is triggered by 2 shocks in 20 minutes;

(c) during the period from 12 hours up to 36 hours after return ofcontrol, takeover #2 is triggered by 2 shocks in 15 minutes; and

(d) during the period from 36 hours up to 72 hours after return ofcontrol, takeover #2 is triggered by 2 shocks in 10 minutes;

Thereafter the takeover criteria return to those that were in effectbefore any shocks were delivered; i.e. at that point the second takeovercriteria equal the first takeover criteria.

FIG. 70 shows an example of time dependent second return of control. Inthe example, with the passing time after second takeover, aprogressively greater degree of normalization of the heart rate isrequired in order to allow second return of control. The algorithm shownmight follow that shown in FIG. 68 (showing time dependent first returnof control for a tachycardia managed by an ICD, which in turn followsfrom the algorithm shown in FIG. 61 showing an example of takeover andreturn of control for heart rate of 200 b.p.m.). Compared to the FIG. 68algorithm, that shown in FIG. 70 entails (i) a more rapidly evolvingreturn of control criterion, as well as (ii) a more demanding one ([1]Heart rate decrements in each step are by larger amounts in FIG. 70, and[2] Each progressive step requires a greater duration of more favorableheart rate before return of control is allowed.). The FIG. 70 algorithmspecifically calls for:

-   -   (a) Within the first 2 minutes after second takeover, second        return of control occurs if the heart rate falls to 190 b.p.m.        or below for 2 minutes;    -   (b) From 2 minutes up to 4 minutes after second takeover, second        return of control occurs if the heart rate falls to 170 b.p.m.        or below for 3 minutes;    -   (c) From 4 minutes up to 8 minutes after second takeover, second        return of control occurs if the heart rate falls to 150 b.p.m.        or below for 5 minutes;    -   (d) From 8 minutes up to 16 minutes after second takeover,        second return of control occurs if the heart rate falls to 140        b.p.m. or below for 8 minutes; and    -   (e) After 16 minutes, return of control may no longer be        possible.

In a preferred embodiment of the invention—if an algorithm called forlockout of the automated return of control—the MP would, if he/shedeemed appropriate, be able to reset the system to allow return ofcontrol to the entity from which it was taken.

Generalized versions of the aforementioned time dependent takeovers andreturns of control will be apparent to those skilled in the art.

The aforementioned discussion of FIGS. 59-70 may involve the transfer ofcontrol between two entities, has been presented in terms of thetransfer of control back and forth between two entities: In generalterms, the takeovers involve the transfer of control from Entity #1 toEntity #2 and the returns of control are from Entity #2 to Entity #1.However, more complex scenarios are possible in which:

(a) The first round of takeover and return of control is between Entity#1 (e.g. an IMD) and Entity #2 (e.g. a patient device), and a secondround of takeover and return of control is between Entity #1 and Entity#3 (e.g. a medical expert device), v.i.z.:

-   -   (i) first takeover transfers control from Entity #1 to Entity        #2;    -   (ii) first return of control transfers control from Entity #2 to        Entity #1;    -   (iii) second takeover transfers control from Entity #1 to Entity        #3; and    -   (iv) second return of control transfers control from Entity #3        to Entity #1.

(b) A cyclic process occurs in which:

-   -   (i) first takeover transfers control from Entity #1 to Entity        #2;    -   (ii) second takeover transfers control from Entity #2 to Entity        #3; and    -   (iii) return of control transfers control from Entity #3 back to        Entity #1; and

(c) A more complex series of handoffs occurs in which:

-   -   (i) first takeover transfers control from Entity #1 to Entity        #2;    -   (ii) second takeover transfers control from Entity #2 to Entity        #3;    -   (iii) first return of control transfers control from Entity #3        to Entity #2; and    -   (iv) second return of control transfers control from Entity #2        to Entity #1.        In the scenarios listed above as (b) and (c), a change in the        sequence of transfer types is presented: i.e. a second takeover        occurs before the first return of control. Specific examples        will be apparent to those skilled in the art, as will be        examples of complex scenarios involving third (and higher order)        takeovers and returns of control, and scenarios involving more        than three entities.

8.0 Use of Function* for Triage

As indicated hereinabove, notification, the process of sendinginformation from a monitoring device (i.e. the IMD, or the patientdevice), the “notifying party”, to any other entity of the IMD system(i.e. the patient device, the patient the M.E. device or the MP), the“notified party”, may be viewed as an invitation to take over control.Because different entities may have different notification criteria,there is the opportunity to set up a control structures with all degreesof complexity. FIGS. 71A to 76C illustrate a number of examples of suchstructures.

Notification is a feature of all of the algorithms of FIGS. 29 to 56Band is discussed explicitly in conjunction with FIGS. 53-56B. Theprogramming of notification in an IMD system has been discussed inconjunction with FIG. 6 (by the patient) and 13 (by the MP). Thetransmission of notification signals by the IMD is shown in FIG. 8, andthe receipt of notification signals by the patient device is shown inFIG. 9. The receipt of notification programming signals by the IMD isshown in FIG. 11. The arithmetic blending of patient information toproduce Function* is presented in FIGS. 22A-24. Notification examplesare shown in the examples in FIGS. 78-82. Second notification—i.e.notification concerning an event temporally related to that whichtriggered first notification—is illustrated by the control screen shownin FIG. 13 and the example in FIG. 82; The latter also illustrates timedependent second notification criteria.

The simplest notification structure would be one in which thenotification occurs for all detected abnormalities, or for alltreatments—for example an ICD which notifies an MP for each time ittreats a tachycardia. Advantages related to more refined notificationformats—in which notification occurs only for some but not all eventsare (a) a decrease in batter power consumption of the notifyingdevice—especially important if that device is the IMD, (b) a decrease inattention time and effort required of a human if the automaticfunctioning of a device suffices, and (c) decreasing the frequency ofcomplex device-device and device-human interactions.

8.1 2-Zone Formats

It thus becomes desirable to consider notification formats in whichnotification occurs for some but not all events, and in which the IMDfunctions autonomously (including the possibility of monitoring but nottreating) for the remainder of events. FIGS. 71A and 71B show simpleformats in which the IMD functions autonomously for events considered tobe normal (in which case it provides no therapy), and for events whichconstitute non-severe abnormalities (for which it treats the conditionbut provides no outside notification). However, in the event of a severeabnormality: (a) notification of both the patient and the MP and IMDtreatment is shown in FIG. 71A, and (b) notification of both the patientand the MP without IMD treatment is shown in FIG. 71B. In the FIG. 71Aformat, the purpose of notifying them and instituting IMD treatmentwould be to allow them to override the treatment if they so desired, butto get the treatment started while they are briefed about andconsidering their own views about treatment; This might be the case fora very high blood sugar, where at least some insulin administration isdesirable, but where the exact amount may be best determined by a human.In the FIG. 71B format, no treatment occurs without the patient or MPauthorizing it; This might be the case for high frequency electrogramsignals which might be due to a defibrillator lead malfunction.

FIGS. 71A-F illustrate notification structures in which the severity ofthe abnormality is denoted by an increasing value of the arithmeticentity Function*. Function * is discussed hereinabove in conjunctionwith FIGS. 22A-24; It may be as simple as heart rate, or a more complexsummation of a number of parameters, each appropriately weighted. Thehorizontal lines in each figure are intended to indicate boundaries forFunction * values, as shown in FIGS. 22A and 22B. Thus FIG. 71B couldillustrate (a) a normal heart rate range up to 160 beats per minute, (b)an ICD treatment only range of 160 to 400 beats per minute, and (c) anotify patient and MP range for greater than 400 beats per minute.

FIGS. 71, 72, 74 and 75 illustrate “half formats,” i.e. formats in whichthe zone with the lowest value of Function* is the normal range; FIGS.73 and 76 illustrate full formats. Half formats are appropriate when theIMD only treats and notifies for elevated values of Function*. Thoughhalf formats are useful for simplifying the illustrative process, manyactual devices will require at least one of treatment or notificationfor values os Function* which are above or below the normal range. Anexample of the latter is an ICD which performs bradycardia pacing forlow heart rates and defibrillation for high heart rates (in which caseFunction* may simply be the heart rate).

The formats in FIGS. 71-76 involve three entities, i.e. the IMD, thepatient and the MP. Formats involving four or more entities (e.g. theIMD, the patient, the M.E. device and the MP) are possible and aregenerally more complex. Two-entity formats are also possible.

Simple formats—those in FIG. 71—are considered to be those in whichnotification, when it occurs, always involves both the MP and the PT.The complex formats of FIGS. 72-76 illustrate some zones in which onlyone of the MP and PT is notified.

FIGS. 71C and 71D illustrate notification formats in which:

-   -   (a) for non-severe abnormalities, the patient and MP are        notified, without IMD treatment; and    -   (b) for severe abnormalities, there is IMD treatment either with        (71D) or without (71C) notification of the patient and MP.

FIGS. 71E and 71F illustrate notification formats in which:

-   -   (a) for non-severe abnormalities, the patient and MP are        notified, with IMD treatment; and    -   (b) for severe abnormalities, there is either notification of        the patient and MP (71E) or IMD treatment (71F).

FIG. 71 show all six possible two zone half-formats in which neither orboth the MP and the patient are simultaneously notified. Formats inwhich one (or neither or both) the MP and the patient are simultaneouslynotified are more numerous; There are 42 possible two zone formats ofthis type. The six such formats in which a non-severe abnormality (asevaluated by Function*) results in IMD treatment without anynotification, after shown in FIGS. 72A-72F:

-   -   Formats in which a severe abnormality results in patient        notification are shown with (FIG. 72A) and without (FIG. 72D)        IMD treatment in the severe zone;    -   Formats in which a severe abnormality results in MP notification        are shown with (FIG. 72B) and without (FIG. 72E) IMD treatment        in the severe zone; and    -   Formats in which a severe abnormality results in both patient        and MP notification are shown with (FIG. 72C) and without (FIG.        72F) IMD treatment in the severe zone.

There are numerous (1764) possible two-zone full formats in which,within any zone there is at least one of (a) IMD treatment, (b) patientnotification, and (c) MP notification. Three such formats areillustrated in FIGS. 73A-73C.

FIG. 73A is symmetrical, in the sense that upward and downwarddeviations from normal have identical notification formats. Fornon-severe deviations from normal (both upward and downward), the IMDoperates autonomously, and for more severe deviations, there is both IMDtreatment and patient notification. As indicated hereinabove, patientnotification is considered an invitation to patient action. Possiblepatient actions include (a) the patient overriding the decision of theIMD to treat, (b) the patient causing the IMD to provide less aggressivetreatment, (c) the patient causing the IMD to provide more aggressivetreatment, and (d) the patient consulting with either an M.E. device orthe MP.

FIG. 73B illustrates a non-symmetrical notification format. It isidentical to that of FIG. 73A except that for severe deviations of thevalue of Function* from normal in the downward direction, the MP (ratherthan the patient—as is the case in FIG. 73A) is notified. An examplewould be a severely decreased value of blood sugar, in whichcircumstance patient functioning may be so impaired that MP (rather thanpatient) notification is advisable.

FIG. 73C illustrates a greater degree of asymmetry, in that the numberof notification zones for downward deviation from normal (one) differsfrom the number for upward deviation (two). An ICD-pacemaker which (a)paces for slow heart rates, (b) defibrillates for high heart rates and(c) defibrillates and notifies the patient for extremely high heartrates is one possible scenario. (The aforementioned scenario mightinvolve patient notification for short bursts of very high rates, andICD treatment for very high rates last more than six consecutiveseconds.) Alternatively, the zone with the highest values of Function*could involve IMD treatment and MP notification, or could involve MPnotification only.

8.2 3-Zone Formats

FIGS. 71-73 illustrate two zone formats: FIGS. 74-76 illustrate threezone formats. FIG. 74 illustrate simple three zone formats, i.e. thosein which, if patient notification occurs, MP notification also occurs.There are 12 possible three zone half formats, six of which are shown inFIGS. 74A-74F.

In FIG. 74A, (a) for mild abnormalities of Function*, IMD treatment onlyoccurs; (b) for moderate abnormalities of Function*, IMD treatment andpatient and MP notification occur; and (c) for severe abnormalities ofFunction*, only patient and MP notification occur. Such a notificationformat is another one that could be utilized for a potentiallymalfunctioning ICD lead system.

FIGS. 74B and 74C both illustrate formats in which:

-   -   (a) for mild abnormalities of Function*, IMD treatment and        notification of both patient and MP occur;    -   (b) for moderate abnormalities of Function*, IMD treatment only        occurs; and    -   (c) for severe abnormalities of Function*, patient and MP        notification with (74C) and without (74B) IMD treatment occur.        A scenario in which such formats might be programmed is        situations in which there is both (i) concern about ICD lead        function [leading to the programming for severe values of        Function* abnormality] and (ii) concern about whether the        programming of a treatment for a mild tachycardia actually        constitutes overtreatment.

FIGS. 74D and 74E both illustrate formats are similar to FIGS. 74C and74B respectively, differing only in the approach to mild abnormalitiesof Function*. In FIGS. 74D and 74E:

-   -   (a) for mild abnormalities of Function*, notification of both        patient and MP occur;    -   (b) for moderate abnormalities of Function*, IMD treatment only        occurs; and    -   (c) for severe abnormalities of Function*, patient and MP        notification with (74D) and without (74E) IMD treatment occur.

A scenario in which such formats might be programmed is situationssimilar to the scenario discussed in conjunction with FIGS. 74B and 74C,now differing in that for mild tachycardias, notification withouttreatment is programmed.

In the situation for which notification is programmed as per FIG. 74F,the patient and MP are notified for any degree of abnormality ofFunction *, but IMD treatment occurs only for intermediate ranges ofFunction* elevation.

In FIG. 75 complex three-entity half formats, in which notificationcriteria for the MP and for the patient are not necessarily identical,are presented. FIGS. 75A-75C show three formats in which (1) there isIMD therapy in all zones, and (2) the zone for mild abnormalities ofFunction* results in autonomous IMD therapy, and (3) notification occursin each of the zones for moderate and severe abnormalities of Function*,as follows:

-   -   in the FIG. 75A format: (i) notification of patient only, for        moderate abnormalities and (ii) notification of patient and MP        for severe abnormalities;    -   in the FIG. 75B format: (i) notification of patient and MP for        moderate abnormalities and (ii) notification of MP only, for        severe abnormalities;    -   in the FIG. 75C format: (i) notification of patient only, for        moderate abnormalities and (ii) notification of MP only, for        severe abnormalities.

In FIGS. 75D and 75E the IMD operates autonomously in the event of amoderate abnormality of Function*, while notification without IMDtherapy occurs in both the mild and the severe zones, as follows:

-   -   in the FIG. 75D format: (i) notification of patient only, for        mild abnormalities and (ii) notification of MP only, for severe        abnormalities; and    -   in the FIG. 75E format: (i) notification of MP only, for mild        abnormalities and (ii) notification of MP and patient for severe        abnormalities.

The format for FIG. 75F is identical to that of 75E, except that MPnotification is added to the zone for moderate abnormalities ofFunction*.

FIG. 76 shows three full formats involving three zones. FIG. 76A, showsa symmetrical format in which IMD treatment occurs in all zones, and inwhich:

-   -   (a) the IMD functions autonomously for mild abnormalities of        Function*;    -   (b) patient notification occurs for moderate abnormalities (i.e.        either above or below the normal range); and    -   (c) patient and MP notification occur for severe abnormalities.

The format illustrated in FIG. 76B is an example of an asymmetricnotification. It is identical to 76A except that for the lowest valuesof Function * (i.e. the lowest zone in the diagram, constituting asevere abnormality with values of Function* in the lowest range belownormal), only MP notification occurs (as opposed to both patient and MPnotification shown in FIG. 76A).

The format illustrated in FIG. 76C shows an example of a greater extentof asymmetry in that there is only one zone below the normal range (inwhich the IMD operates autonomously, i.e. without notifying either thepatient or the MP); and there are three zones above the normal range inwhich:

-   -   (a) for mild abnormalities, the IMD operates autonomously,    -   (b) for moderate abnormalities, the IMD applies treatment and        notifies the patient; and    -   (c) for severe abnormalities, the IMD applies treatment and        notifies both the patient and the MP.        Such a notification format could also be used to institute        corrective action in the case of a defective ICD lead.

9.0 Clinical Examples, Overview

FIGS. 78-82 show a selected set of examples of clinical situations inwhich the IMD-system functions advantageously. FIG. 77 shows a tablewhich summarizes the examples in shown FIGS. 78-82.

Referring to FIG. 77, summarizes five exemplary figures related to fourclinical scenarios. The IMD system which is the subject of FIG. 78 is ablood sugar control system, and the IMD which is the subject of theremaining figures is an ICD. The system and component descriptionsdescribed hereinabove are not limited to these two types of IMDs, asindicated hereinabove. In columns four through seven, the tableclassifies the one or more transfer(s) of control from one system entity(e.g. the IMD) to another (e.g. the patient), during the example. The“>” signs in the headings and subheadings of each column are intended tobe read as the words “takes control from”. Thus the heading of columnfour, “DEVICE>DEVICE” is read as “device takes control from device”, andthe subheading below and to the left, “PT.sub.DEV>IMD” is read as“patient device takes control from IMD”. Examples of each of:

(a) device taking control from device;

(b) device taking control from a human;

(c) human taking control from a device, and

(d) human taking control from a human

are presented. When horizontal lines divide the information about one ofthe figures into two or three sections, the figure indicates more thanone scenario. The numerals in columns 4-7 and the associated sub-columnsindicate the sequence of control transfers. For example, the “A” exampleshown in FIG. 78 involves, sequentially, the transfer of control from:(1) the IMD to the patient;(2) then, from the patient to the patient device;(3) and then, from the patient device to the medical professional.

9.1 Blood Sugar Management

FIG. 78 illustrates an example of a patient with an implanted insulinpump. In the system that is the subject of the example, the pump mayfunction autonomously or may be controlled externally. In the example,the device detects a high blood sugar and notifies the patient, havingbeen programmed to have patient notification criteria that trigger thisnotification. The patient, not satisfied with device management, takescontrol from the implanted device and causes it to deliver additionalinsulin. Following the additional insulin, the blood sugar falls to alow value (45 mg./dl.); The implanted device detects the low value, hasbeen programmed to notify the patient device of the low value, and doesso (the choice of patient device over patient as the notification targetis based on the concept that with a blood sugar as low as 45 mg./dl.,the patient's judgment may be impaired.

The patient device then interrogates the patient to check his/herjudgment. Hardware FIGS. 4, 5 and 6 are relevant to such aninterrogation; the control screen shown in FIG. 18 shows the programmingof such an interrogation (though it is not the screen that would be usedfor patient responses [if a screen is used]). A very similar algorithmto the one shown in FIG. 25 for patient interrogation by an IMD, couldbe utilized for patient device interrogation (This is discussed in thespecification for FIG. 25 hereinabove.). The flow diagram in FIG. 78then bifurcates into an “ExampleA”, and “Example B”.

Referring to the Example A, the patient device, upon determining thatboth the patient and the IMD have not managed the insulin dosage withsatisfactory result, locks outpatient control. FIG. 10 shows a controlsignal “COMMANDS AND SUGGESTIONS FOR IMD FROM PATIENT DEVICE” whichaccomplishes such a task. Algorithm figures which illustrate such apatient device include FIG. 51 (for a 5-entity system), FIG. 39 (for a3-entity system). In addition, the programming of the control hierarchyshown in line 3 of FIG. 14 (C1 conditions), in association with avariant of the FIG. 56B algorithm (discussed hereinabove in conjunctionwith FIG. 56B) could allow the patient device to have this level ofcontrol.

Referring again to FIG. 78, in addition to patient control lockout, thepatient device:

(a) causes the IMD to interrupt or decrease the rate of insulin infusion(if it is still being administered);(b) notifies the patient to take in more glucose immediately, ifpossible; and(c) optionally notifies a family member, neighbor, or the patientsphysician.In the example, the blood sugar then rises to 350 mg./dl. This isdetected by the IMD which is programmed to notify the MP under suchcircumstances. (In other possible examples, the IMD, the patient device,or any other entity could be programmed to deal with this glucoseelevation.)

The MP: causes the IMD to increase the insulin dose, and, because of therecent instability of the clinical situation, manages it himself/herselffor a period of three hours (Numerous other variations are possible.).Before returning control to the IMD, the MP reprograms:

(a) insulin management by the IMD; and(b) the criteria for the IMD to notify the patient of hyperglycemia, toa lower notification value.When the MP is convinced that the situation has stabilized, the MPreturns control to the IMD and, in the example:(a) instructs the patient in better management techniques and, ifsatisfied with the patient's comprehension of them and the newlyre-established clinical stability, re-enables the patient's access toIMD control;(b) reprograms the patient device's insulin management and may reprogramthe patient lockout criteria; and(c) activates a “watchdog” function of the medical expert device, whichthe MP instructs to takeover control if, at any time during the upcoming72 hours the blood sugar excessively rises (e.g. to >300 mg./dl/) orfalls (e.g. to <50 mg./dl.).

In Example B of FIG. 78, at the time when significant hypoglycemiaassociated with impaired patient judgment is detected, the patientdevice, instead of itself taking control, seeks to notify the MP so thathe/she may take control. If the MP cannot be contacted because of acommunications problem, any of the device entities (M.E. device, patientdevice or the implanted device) may be chosen; The choice would havebeen pre-programmed by the hierarchy control screen of FIG. 14. As isthe case with Example A, the patient device also (a) locks outpatientcontrol, (b) notifies the patient to take in more glucose, and (c) maynotify a family member or neighbor.

The MP, when contacted performs all of the steps performed by the MP inExample A, except for reprogramming the patient device, since in ExampleB, management by the patient device has not led to a clinical problem(as was the case in Example A).

A very large number of possible variations of this example, in terms ofsystem entities involved, their respective actions, and in terms of theclinical scenario itself are possible, and will be obvious to thoseskilled in the art.

9.2 Ventricular Tachycardia Management

FIGS. 79 and 80 show examples in which the IMD is an ICD and fails todetect an episode of ventricular tachycardia, because the VT rate isless than the programmed VT detect rate of the ICD. In both examples,the problem is detected by the patient device. In the version shown inFIG. 79 (referred to as the “A” example in FIG. 77), the ICD is notifiedby the patient device and resolves the problem. In the version shown inFIG. 80 (referred to as the “B” example in FIG. 77), the MP is notifiedby the patient device and resolves the problem.

Referring to FIG. 79: VT at 160 b.p.m is not detected by the ICD whichis programmed react to tachycardias with a rate greater than 182 b.p.m.The patient device may detect the tachycardia in a variety of ways:

(a) a heart rate sensor, either attached to the patient, or worn by thepatient or implanted in the patient may detect the tachycardia. In thelatter case (implanted device detects tachycardia), the implanted devicemay be either (i) a device other than the ICD which detects thetachycardia, or (ii) the ICD itself, which may be programmed to reportheart rates which are rapid (but less rapid than the programmedtreatment rate cutoff) to the patient device;(b) via any of the apparatus (discussed in conjunction with FIG. 5 andcontrol screen FIG. 21 [See also the Function* example of FIG. 24.]) forthe detection of a patient fall or loss of consciousness. In this case,the patient device may confirm that treatment us warranted byinterrogating the patient and determining that the patient isunresponsive;(c) via abnormalities which may be detected by one or more othersensors, e.g. respiration, GSR, pulse oximeter or other pulse monitoringdevice, etc.Up to this point in the example, FIGS. 79 and 80 are identical; afterthis point, they diverge. The determination by the patient device thatthe patient is tachycardic and unresponsive leads, in the example shownin FIG. 79, to the patient device selecting the IMD as the source ofmanagement. An algorithm illustrating such a process is shown in FIG.35. The ICD is informed of the problem, and of its selection as theentity to terminate the tachycardia. It may use a preprogrammedalgorithm for management in such circumstances, or alternatively, may beinstructed by the patient device. The tachycardia is thus terminated bythe ICD.

The MP may be informed of these events (a) following the tachycardiatermination, or (b) earlier, at the time that the ICD is informed (orneither (a) nor (b)). The MP may then interrogate the ICD and reprogramone or more of:

(a) tachycardia detection criteria;(b) tachycardia termination parameters;(c) MP notification criteria; and(d) criteria for notification of the patient device by the IMD (e.g tonotify the patient device of tachycardia in the range of 160 b.p.m., ifthis has not already been done).

In the algorithm shown in FIG. 80, at its point of divergence from theFIG. 79 algorithm, the patient device selects the MP for management andnotifies it (e.g. in a FIG. 35-like algorithm). The MP receives thenotification, and information pertinent to managing the current event.The MP may bypass interrogation and go directly to a control point inthe ICD algorithms, e.g. for performing a non-invasiveelectrophysiologic test, or may formally interrogate the patient's ICDfirst. The MP then causes the ICD to terminated the tachycardia, eitherby directly selecting the therapy and causing its administration, or byprogramming the ICD to sense a tachycardia at a rate of 160 b.p.m. or aslower rate. The MP may then do one or more of:

(a) formally interrogate the ICD if he/she has not already done so;(b) reprogram the tachycardia detection rate and other detectionenhancement criteria (if not already performed);(c) reprogram the MP notification criteria; and(d) reprogram the criteria for notification of the patient device by theIMD.

FIG. 81 shows an example in which the patient device is able todetermine that signals detected by an ICD and labeled as VT are actuallymake-break signals from a failing ICD lead (or header). The examplebranches in Examples A, B and C. In the common initial portion of theexample, the following features are shown to be programmed into the ICD:

(a) VT detection at 180 b.p.m. for 12 out of 16 beats;(b) Notify the patient device for rate >300 b.p.m. for 12 out of 16beats; and(c) Notify the MP for rate >300 for 30 out of 40 beats, occurring threetimes within a two hour moving window of time.

Because of the ICD lead malfunction, make-break signals are producedintermittently. At one point, 18 such events (with rate corresponding toover 300 b.p.m.) occur in close enough proximity to satisfy the ICD'spatient device notification criterion, and patient device is informed.The patient device may have ECG capability if either (a) there is anattached, worn or implanted ECG sensing device already in place (seediscussion in conjunction with FIG. 79), or (b) if the patient device,upon receipt of the information indicating the detection of extremelyrapid VT, requests that the patient attach such an ECG monitoringdevice. (The patient could also be queried by the patient device, as towhether any symptom (e.g. dizziness) occurred in temporal relation tothe high rate electrograms, with a negative answer being suggestive thatthe high rate electrograms do not correspond to a clinical rhythmabnormality.) The patient device may also, as indicated in conjunctionwith FIG. 79, be able to determine the non-concordance of the high rateelectrogram signal with a clinical rhythm abnormality via one or moreother external sensors.

Once the patient device has the opportunity to demonstrate that the highrate electrograms do not have a clinical correlate, it concludes thatthe signal represents either make-break events, or electromagneticinterference. At this point, the example shown in the figure has threebranches.

In the branch corresponding to Example A, the patient device notifiesthe ICD. The ICD may then ignore the corresponding event, and theprocess (of ICD detection of high rate electrograms, followed bynotification of the patient device, followed by notification of the IMDto ignore the event) may continue to repeat. Alternatively, the ICD maybe pre-programmed to allow self-programming to a longer detect window(e.g. 25 out of 35 beats instead of the previously programmed 12 out of16 beats), upon notification of the ICD of the non-physiologic nature ofthe event, by the patient device. Other self-programming options includeone or more of

(a) the reprogramming (shortening) of the time to redetect sinus rhythm(making it less likely that back-to-back flurries of make-break signalsare inappropriately detected as a single longer event;(b) changing the sensitivity for electrogram detection; and(c) changing other signal processing characteristics such as thefiltering of the electrogram signals.(In an ICD with multiple parallel analysis algorithms, each of thealgorithms could process the electrogram signals differently (e.g.different filtering, different gain, etc.) and the outputs of thealgorithms could be compared (as discussed in conjunction with FIG.57).)

In the branch corresponding to Example B, the control hierarchy (e.g. asset up by the screen shown in FIG. 14) is such that the patient devicemay reprogram the ICD. In the example, the detect duration is increasedto 25 out of 35 events. In addition, ICD notification of the patientdevice is reprogrammed so that only a shorter number of make-breaksignals (6 out of 9) is required to trigger notification of the patientdevice.

In both the Example A and Example B, the next event is ICD detection ofan even longer run of high rate electrograms—32 out of 37 beats—which islong enough to trigger MP notification by the ICD. Example C led to MPnotification by the patient device without any patient deviceinteraction with the ICD. All three examples converge following MPnotification.

In the example, the MP consults the M.E. device, which searches itsdatabase for relevant information, i.e.

(a) information about this patient's medical (and ICD and lead) history;(b) general product information about the patients ICD and lead;(c) stored electrogram samples which may include [i] samples from thispatient at prior times, [ii] samples from other patients who haveexperienced a lead malfunction (emphasizing cases of malfunction of thesame lead and device combination), [iii] samples from other patients whohave experienced header or other ICD malfunctions which may manifest inthe generation of abnormal sensed signals, and [iv] samples from otherpatients experiencing known electromagnetic interference.Based on the analysis of the aforementioned, the M.E. device concludesthat the recorded electrograms have a high likelihood of beingconsistent with lead malfunction, and so informs the MP. The MP then:

(a) reprograms the ICD for a still longer VT detect period (35 out of 45beats);

(b) reprograms a shorter sinus rhythm redetect time;

(c) reprograms a lesser degree of sensitivity on the ventricularelectrogram channel of the ICD;

(d) reprograms ICD notification of the MP to have an identical durationas does ICD detection, and turns off patient device notification(preferring to handle the problem directly);

(e) informs the patient via the patient device; and

(f) informs the patient's MD and any necessary quality controlperson(s).

FIG. 82 shows an example of an ICD with three independent VT detectionalgorithms operating essentially simultaneously, in parallel. ICDprogramming is such that, for non-extreme rhythm abnormalities (e.g.rate less than 200 b.p.m.) the majority rules, i.e. if the algorithms donot agree as to whether an event is or is not VT, then the decision ofthe two algorithms which agree is accepted. The ICD is furtherprogrammed so that under certain compelling circumstances, either thepatient or the patient device may overrule the ICD decision.

The patient, with ICD so programmed, develops a tachycardiacharacterized by rate 170 b.p.m., a prolonged QRS duration and anelectrogram morphology suggestive of VT, and a 1:1 relationship betweenatrial and ventricular events, with AV timing not classic forsupraventricular tachycardia. Two of the ICD algorithms diagnose VT,while the third diagnoses supraventricular tachycardia (“SVT”). The ICDaccordingly treats the event as VT, and delivers two shocks, neither ofwhich terminate the tachycardia. (In an alternate example, the initialmajority diagnosis may be SVT, but after the programmed period oftherapy inhibition for SVT elapses without SVT termination, VT therapyis delivered.)

In Example A, the patient, aware of the tachycardia but not feelingcompromised by it inhibits ICD therapy by inputting a correspondingcommand to the patient device; This would be allowable if the previouslyprogrammed control hierarchy gave this power to the patient. The patientdevice then signals the ICD to inhibit therapy, and the M.E. device isnotified.

In Example B, after the two patient shocks, the patient devicedetermines that the patient is uncompromised:

(a) by utilizing information obtained from one or more physiologicsensors, e.g. [i] a blood pressure device (which the patient devicemight ask the patient to apply); [ii] a sensor for the determination ofskin resistance (expected to be elevated if the patient is significantlycompromised because of an increase in sympathetic tone associated withthe compromised state) and/or [iii] a sensor for one or more of oxygenor carbon dioxide; and/or(b) by patient interrogation.

When the patient devices makes this determination it signals the ICD toinhibit therapy (the ICD having been programmed to allow suchinhibition), and the M.E. device is notified.

At this point, Example A and Example B become identical. The M.E.device, (a) by analyzing signals from the ICD electrograms and/or theanalyses of each of the ICD algorithms (transmitted as per FIG. 8),and/or (b) by consulting its event library (see FIG. 12), concludes thatthe tachycardia is supraventricular in origin, and that defibrillatorshocks are inappropriate. It then causes the ICD to deliverantitachycardia pacing in the ventricle (the details of which are basedon either (a) data from the M.E. device event database, (b) an algorithmavailable to the M.E. or (c) an algorithm resident in the ICD), whichsuccessfully terminates the SVT. The M.E. device may cause the ICD todeliver the ATP by (a) accessing control to the non-invasiveelectrophysiologic testing function, or (b) programming the ICD todeliver ATP for the SVT under consideration. The M.E. device will havebeen given the permission to control the ICD in this manner because ofprevious programming of the control hierarchy setup (see, for example,FIG. 14).

Following tachycardia termination, the M.E. device then reprograms theICD to deliver ATP similar to that which terminated the tachycardia (ifsuch programming was not performed prior to the tachycardiatermination). The M.E. device may also reprogram a time dependent MPnotification sequence, for enhanced MP notification over the following72 hours (the baseline criterion having been 3 shocks in 10 minutes (seea similar algorithm for second takeover in FIG. 69), e.g. that MPnotification (and hence possible MP takeover) is to be triggered:

(a) during the next 3 hours, by 2 shocks during a moving window of 25minutes duration; then(b) during the following 9 hours, by 2 shocks during a moving window of20 minutes duration; then(c) during the following 24 hours, by 2 shocks during a moving window of15 minutes duration; then(d) during the following 36 hours, by 2 shocks during a moving window of10 minutes duration; and followed then by(e) a return to the previously programmed format of MP notification bythe IMD for 3 shocks during a moving window of 10 minutes duration.

The M.E. device then observes the patient continuously for the next hourto check for ongoing stability, and then returns control to the ICD.

In the last phase of the example, the supraventricular tachycardiarecurs 8 hours later. The ICD, whose detection algorithm was notreprogrammed by the M.E. device, again diagnoses VT, but this timedelivers the programmed ATP. However, the ATP is unsuccessful, and isagain followed by two ICD shocks within a few minutes. This triggers MPnotification.

The MP diagnoses SVT, as did the M.E. device. He/she access ICD controlby (a) accessing control to the non-invasive electrophysiologic testingfunction, or (b) programming the ICD to deliver ATP for the SVT underconsideration. The MP choice of the ATP parameters (and perhaps the siteof stimulation [i.e. the atrium]) differ from that utilized successfullyby the M.E. device but, later, unsuccessfully by the ICD. The MPinhibits autonomous ICD therapy and delivers his/her choice of ATP whichsuccessfully terminates the tachycardia. The MP then programs one ormore of:

(a) the successful ATP format that was used to terminate the current SVTepisode;

(b) a shorter tachycardia detect time, thereby hoping to furtherincrease the likelihood of successful pacing termination;

(c) a separate detection and treatment zone/regime which encompasses theSVT in question, and which detection results only in ATP and not in ashock;

(d) bradycardia pacing at a different rate, hoping that such programmingmay lessen the likelihood of SVT recurrence; and

(e) an altered value of post ventricular atrial refractory period(“PVARP”), or of PVARP extension post premature ventricular beat, alsohoping to lessen the likelihood of SVT recurrence.

The MP also reprograms the criteria for ICD notification of the MP fromthe present setting of 2 shocks in 20 minutes to: (a) for the next 72hours, any shock, and (b) thereafter to return to the default value of 3shocks in 10 minutes. The MP observes the patient for 2 hours and thenreturns control to the ICD.

The aforementioned examples in described in FIGS. 78-82 are intendedeasily to illustrate various advantageous features of the currentinvention. The examples do not illustrate all of the features, and donot cover all of the many types of implantable medical devices which maybe controlled by the system and methods described herein.

Abbreviations

ATP=antitachycardia pacingBS=blood sugarEEG=electroencephalogramGSR=galvanic skin resistanceHR=heart rateICD=implantable cardioverter defibrillatorIMD=implanted medical deviceM.E. device=M.E.D.=MEdev=medical expert deviceMP=medical professionPT=patientPT device=PTdev=PT.D.=patient deviceRR=respiratory rateRS=remote stationSVT=supraventricular tachycardiaVT=ventricular tachycardiaFIG. 83 shows a SAV—a semi-autonomous vehicle. The architecture for thesystem has some conceptual common ground with that of the hierarchicalsystem for the management of IMDs. Shown are a vehicle, the SAV, withvehicle sensors and vehicle control devices—e.g. throttles, brakes,steering apparatus etc. A communication system (“COMMS”) links thecomputational [including a microprocessor system (i.e. one or moremicroprocessors and/or microcontrollers and the like) with interfacecircuits and memory] to the control devices and to the sensors. Anoptional human driver—another source of control—is present, and ismonitored by driver sensors. Off-vehicle are the TP, a regional TEdevice and a local TE device.FIG. 84A is a block diagram showing system architecture for SAVmanagement by multiple sources of control. The parallels to the IMDsystem of FIG. 1A are seen. The control entities include the SAV 3102(with numbered squares within it referring to multiple parallelalgorithms), the human driver 3100, a driver device 3104 (which monitorsthe driver and may interact with the driver during evaluation), a TEdevice 3106 and a TP 3108 linked through remote station 3110.FIG. 84B is a block diagram of a SAV system with two or more sources ofcontrol. It shows a SAV with two or more operating states, a controlstation and a state setting device for inputting a system hierarch ofpriorities among control entities.FIG. 84C is a block diagram of a SAV system with at least one controldevice and at least one state setting device.FIG. 84D is a block diagram of a SAV system with two additional sourcesof control, one local (e.g. onboard the vehicle and one remote (e.g. theTP or a TE device).FIG. 84E is a block diagram of a SAV system with three additionalsources of control, and FIG. 84F is a block diagram of a generalized SAVsystem with an unspecified number of control stations.FIG. 85 is a block diagram of a SAV 3400. The processor(s) withassociated memory and interfaces 3420 are linked to each of atransmitting device 3412, a receiving device 3414, SAV sensors 3416 andvehicle management devices 3418. The transmitter and receiver may beseparate units, a single transmitting and receiving device, multiplesuch devices, or a hardwire connection allowing signal inflow andoutflow from 3400. The sensors may be a wide array of speed determiningdevices, accelerometers, pressure and temperature monitors, attitudemonitors, fuel, oil, brake fluid and transmission fluid monitors, GPSand other vehicle sensors as are known in the art.FIG. 86 is a block diagram of a human driver unit 3402 within an SAVsystem. Processor system 3426 is coupled to a transmitting device 3434,a receiving device 3432, driver input devices for inputting commands andresults of driver assessment, driver output devices 3424 for displayingwarning signals and test evaluation matter, a driver assessment unit3430 and driver sensors for further assessing driver capability.FIG. 87 is a block diagram of a traffic expert (TE) unit within an SAVsystem. Communications device 3436 is coupled to computational apparatus3438, which in turn is linked to database 3440.FIG. 88 is a block diagram of a human traffic professional within theSAV system. Processor 3439 is coupled to each of: an input device 3443for inputting driving/piloting choices by the TP, display device 3447for displaying sensor and database information, communications device3437 and identification device 3445. Password identification ispossible, but the use of a biologic identifier, as described in theMatos patents and applications incorporated by reference herein resultsin more robust determination that the person performing the TP functionis properly identified. Note that in combination, FIGS. 85 through 88comprise matter which parallels that of FIG. 4A relating to an IMDsystem.FIG. 89 is a block diagram of showing module and system architecture fora SAV system with SAV, an additional vehicle control unit and ahierarchy setting unit. The hierarchy setting device 3476 includes inputdevice 3480, a processor and communications device 3478. It sends thehierarchy setting signal inputted at 3480 to the communications deviceof SAV 3450. The SAV includes a processor 3458 which is linked to eachof communications device 3464, sensor circuit 3454 with output 3456 andwith sensed data input indicated by 3462, and management devices(throttle, brakes etc.) 3452. The “internal control signal” 3460 is themanagement choice generated by the SAV “as if” it were the soledeterminant of vehicle function. This signal is provided to 3452 only ifthe control hierarchy indicates that the internal control signal is thehighest priority. Other possible priorities are the external controlstations 3470, with processor 3472 linked to optional input device 3473(biologic ID desirable), optional display device 3475 and communicationsdevice 3474. In the case of non-human units such as the TE device, theinput and display devices would be unnecessary.FIG. 90 is a representational diagram of a SAV system with monitoringdevices to determine the driver's fitness to drive. Information aboutthe fitness of the driver is provided by camera 3528, microphone 3526,blood gas device 3506, wearable sensors 3514, BP device 504, and via adriver held unit 3502 which may further be used to ask questions of thedriver. Outgoing information is routed via 3520 to 3522 to 3524.FIG. 91 is a representational diagram of a SAV system with a drivercommunications device 3600. Screen 3602 provides driver information andcan be used to interrogate the driver. The driver can request control,take control (if hierarchy permits), surrender control or contact the TPor TE device.FIG. 92A is a block diagram of a SAV which can run multiple parallelalgorithms to make a management determination. Three such algorithms areshown 3710, 3712 and 3714 (the nth one) schematically. These input amaster algorithm along with information from each of the other entitieswhich may control the SAV. Based on the programmed hierarchy (which mayalso give preference to one of the algorithms or indicate a blendingprocedure), an management decision is outputted to a management device.Incoming communication is via 3708 to 3704, and outgoing via 702 to3706.FIG. 92B is a block diagram of a SAV which receives control signals frommultiple external sources and one internal source. The configuration issimilar to that shown in FIG. 92A except for a single algorithm runningin this configuration.FIG. 93 is a block diagram of information which may be transmitted bythe SAV transmitter 3804, with sources 3800, and 3802. Interface device806 links 3802 to 3804.FIG. 94 is a block diagram of information which may be received by theSAV receiver. Hierarchy programming, discussed hereinabove is providedby this route.FIG. 95 is a block diagram of a database for managing a SAV system.Processor 4206 is linked to event library 4204. Incoming communicationsare 4200 to 4202, and outgoing communications are 4208 to 4210.FIG. 96 is a programming and display screen 4300 for managing a SAVsystem. The screen, which may be touch sensitive, and which would be thetype of screen for use by a TP, allows for programming of such criteriaas hierarchy, notification criteria, etc.FIG. 97 is a programming and display screen for managing hierarchywithin a SAV system. This would also be utilized by a TP or a personwith even higher authority who would be allowed to program hierarchy. Inthe configuration shown, hierarchy may be set for a system with up to 5entities.FIG. 98 is a programming and display screen 4500 for managing hierarchycontrol within a SAV system. This allows for “the control of control”,i.e. it allows for the programming of who may program hierarchy.FIG. 99 is a programming and display screen for assessing and managinghuman driver impairment within a SAV system. This screen allows for theprogramming of devices which evaluate a human driver (cameras, attitudesensors, respiratory devices etc.) It's operation is analogous to thatof the patient assessment screen of FIG. 21 discussed hereinabove inconjunction with IMDs.FIGS. 100A and 100B illustrate the use of a mathematical entity whichmeasures SAV and driver condition to determine when a SAV notifies thedriver and when the SAV or driver notify a traffic expert orprofessional. As will be shown in the flow diagrams hereinbelow, theconcept of notification is desirable to screen what would otherwise be atorrential flow of information to TPs and even to TE devices.Notification scenarios determine a level of abnormality that is requiredbefore a change of control entity may be called for. Notification inthis format is analogous to that discussed in conjunction with FIGS. 22Aand 22B for IMDs.FIGS. 101 and 102 are a flow diagram showing use of cognitiveinformation about the driver to determine SAV management.FIGS. 103A and 103B are a table showing the elements in a variety of 2to 5 entity SAV systems. The table pertains to the flow diagrams in thefigures which follow.FIG. 104A to 104C are 2×2 tables showing possible operating states in atwo control entity SAV system. In these simple systems, four states aredefined. The systems include one with an SAV and a human driver, onewith an SAV and a TP, and one with an SAV and a TE device.FIGS. 105 and 106 are a flows diagram illustrating the control of a 2entity SAV system, which may be controlled by each of an SAV and a humandriver. These diagrams distinguish each of: (1) the site wheremonitoring occurs, (2) the site where a determination is made as towhether additional control signals are required, and (3) the site wherethe decision is made as to which entity will provide the additionalsignals, if required.FIGS. 107 to 111 are flow diagrams illustrating the control of a 3entity SAV system, which may be controlled by each of a SAV, a trafficprofessional and a human driver. They differ with regard to the sitewhere a determination is made as to whether additional control signalsare required, and the site where the decision is made as to which entitywill provide the additional signals, if required.FIGS. 112 and 113 are flow diagrams illustrating the control of ageneralized 3-entity SAV system, which may be controlled by any of thethree entities.FIGS. 114 to 116 are flow diagrams illustrating the control of a 4entity SAV system, which may be controlled by a SAV, a human driver anon-human traffic expert device or a human traffic professional.FIG. 117 is a flow diagram illustrating the control of a 3 entity SAVsystem, which may be controlled by a SAV, a human driver a human trafficprofessional. In this configuration the TP and the driver may discusstheir relative positions among the hierarchy.FIG. 118 is another flow diagram illustrating the control of a 3 entitySAV system, which may be controlled by a SAV, a human driver a humantraffic professional, showing notification. In this scenario the TP isassigned a higher priority than the human driver. If no TP response isreceived, the driver's response takes precedence. If no driver responseis received, the SAV response takes precedence.FIG. 119 is yet another flow diagram illustrating the control of a 3entity SAV system, which may be controlled by a SAV, a human driver ahuman traffic professional. This figure is similar to FIG. 118, esceptthat in 119, the driver priority is higher than that of the TP. The SAVhas the lowest priority of the three entities.FIG. 120A is a flow diagram illustrating the control of a 4 entity SAVsystem, which may be controlled by a SAV, a human driver a non-humantraffic expert device or a human traffic professional. The conceptualformat is similar to that of the immediately previous figures. In thisFIG. 120A, the TP has the highest priority, followed by the TE device,followed by the human driver. The SAV has the lowest priority.FIG. 120B is another flow diagram illustrating the control of a 4 entitySAV system, which may be controlled by a SAV, a human driver a non-humantraffic expert device or a human traffic professional. This figure issimilar to that of 120A, except that a more clear indication of how oneentity may be programmed out of the hierarchy cascade is indicated.FIG. 120C is yet another flow diagram illustrating the control of a 5entity generalized system, which may be controlled by any of the fiveentities. This figure is a generalized version, as is FIG. 120D, whichis analogous to 120B and 120C, but is suited to any number of entities.FIG. 121 is a flow diagram illustrating the operation of three parallelalgorithms, for management of an SAV. Outcome options include variousaveraging techniques, utilizing only two of three algorithm outputs orcontacting a human (either the driver or the TP).FIG. 122 is a flow diagram illustrating the operation of two parallelalgorithms, for management of an SAV. The logical underpinnings of thefigure parallel those of FIG. 121 (for three algorithm situations).FIGS. 123 and 124 are flow diagrams illustrating the shifting of controlfrom (“Takeover”) and back (“Return of Control”) to an SAV. They arebased on the arithmetic operation referred to hereinabove as “Function *which allows for the blending of results of multiple sensor outputs intoa single parameter which may ten be utilized to determine whether thecontrol entity which is operating the SAV at the time of the Function *evaluation is fit to continue with the operation.FIGS. 125 and 126 are flow diagram illustrating the repeated shifting ofcontrol from and back to an SAV, based on Function*. A variety ofadditional management options are presented at the bottom of FIG. 126related to the sequence: takeover control followed by restore control tothe entity from whom it was taken away (after an improvement in thevalue of Function*), followed by a second takeover (with a differentthreshold for second takeover than the first takeover), followed by alist of considerations related to a possible second return of control.FIGS. 127A to 127F show graphic representations illustrating thedistribution of information and of management among multiple entities ina SAV system. They illustrate the complexities in the relationshipbetween notification and usurpation of control, and hence the value ofhaving these as programmable parameters.

There has thus been shown and described novel apparatus and methodologyfor controlling an implantable medical device which fulfills all theobjects and advantages sought therefor. Many changes, modifications,variations and other uses and applications of the subject inventionwill, however, become apparent to those skilled in the art afterconsidering this specification and the accompanying drawings whichdisclose the preferred embodiments thereof. All such changes,modifications, variations and other uses and applications which do notdepart from the spirit and scope of the invention are deemed to becovered by the invention, which is to be limited only by the claimswhich follow.

What is claimed is:
 1. Apparatus comprising a semi-autonomous vehicle(SAV) which is alternatively internally controlled and controlled by atleast one additional control source, said SAV comprising, incombination: (a) a first transmitting/receiving (T/R) device configuredto transmit at least one signal representing a state of a SAV to, andconfigured to receive a first additional vehicle control signal from afirst additional control source; (b) a vehicle management deviceconfigured to control said vehicle in response to vehicle managementsignals each representing a vehicle management choice applied thereto;(c) a first sensor circuit, having a first sensor circuit inputconfigured to input SAV information representing a state of said SAV,and having a first sensor circuit output, configured to produce at leastone first sensor circuit output signal in response to said inputted SAVinformation; and (d) a first processor, coupled to each of (1) saidfirst sensor circuit output, (2) said first T/R device, and (3) saidvehicle management device, configured to (A) generate at least one firstSAV information signal representing said inputted SAV information; (B)analyze said at least one first sensor circuit output signal, and, basedon the analysis, generate an internal vehicle control signal; (C) selectone of at least three operating states in response to a received statecontrol signal; and (D) based on said selection, generate said vehiclemanagement signals; wherein: (i) in a first operating state, said firstprocessor is operative to prioritize a vehicle management choicerepresented by said generated internal vehicle control signal, if any,over a vehicle management choice represented by said received firstadditional vehicle control signal, if any; to generate said vehiclemanagement signals, (ii) in a second operating state, said firstprocessor is operative to prioritize the vehicle management choicerepresented by said received first additional vehicle control signal, ifany, over the vehicle management choice represented by said generatedinternal vehicle control signal, if any; to generate said vehiclemanagement signals; and (iii) in a third operating state, said firstprocessor is operative to generate said vehicle management signals basedon both (I) the vehicle management choice represented by said receivedfirst additional vehicle control signal and (II) the vehicle managementchoice represented by said generated internal vehicle control signal;and wherein said first T/R device is further operative to receive saidstate control signal and to provide the information represented by saidstate control signal to said first processor; whereby said firstprocessor selects the source of control of said SAV from among: (i) saidinternal vehicle control signal only; (ii) said first additional vehiclecontrol signal only; and (iii) both of (I) said internal vehicle controlsignal and (II) said first addition vehicle control signal.
 2. A systemcomprising the apparatus defined in claim 1, further comprising acommand station configured to set the operating state of said SAV, saidcommand station including: (a) a command input device, configured toinput a state setting command and configured to generate a commandsignal; (b) a second processor, coupled to said command input device,configured to generate a state control signal in response to saidcommand signal; (c) a command transmitting device, coupled to saidsecond processor, configured to transmit said state control signal tosaid first T/R device; thereby to set the operating state of said SAV.3. A system comprising the apparatus defined in claim 1, furthercomprising a first additional control station configured to control saidSAV, said first additional control station including: (a) a thirdprocessor; (b) a display device, coupled to said third processor,configured to display a representation of said SAV information; (c) aninput device, coupled to said third processor, configured to generate afirst additional control signal in response to an inputted vehiclemanagement choice, and configured to input commands from a person; and(d) a second T/R device, coupled to said third processor, configured toreceive said SAV information signal, and configured to transmit saidfirst additional control signal to said SAV.
 4. A system comprising theapparatus defined in claim 1, further comprising a second additionalcontrol station configured to control said SAV, said second additionalcontrol station including: (a) a fourth processor configured to generatea second additional control signal in response to analysis by saidfourth processor of said SAV information; and (b) a third T/R device,coupled to said fourth processor, configured to receive said first SAVinformation signal, and configured to transmit said second additionalcontrol signal.
 5. The system defined in claim 3, wherein said firstadditional control station is located onboard said SAV; and said inputdevice is arranged to input vehicle management choices of an onboarddriver of said SAV.
 6. The system defined in claim 3, wherein said firstadditional control station is not located onboard said SAV; and saidinput device is arranged to input vehicle management choices of atraffic professional authorized to input vehicle management choices ofsaid SAV.
 7. The apparatus defined in claim 1, wherein said choicerepresented by said internal vehicle control signal comprises a firstnumerical selection pertaining to said vehicle management choice; andsaid choice represented by said first additional vehicle control signalcomprises a second numerical selection pertaining to said vehiclemanagement choice; in said third operating state, upon a determinationby said first processor of said numerical selections, said firstprocessor is operative to generate a vehicle management signalrepresenting a vehicle management choice based on a mathematicalfunction of both said first numerical selection and said secondnumerical selection.
 8. The apparatus defined in claim 7, wherein saidmathematical function is selected from the group consisting of: (a) anaverage, and (b) a weighted average.
 9. The apparatus defined in claim1, wherein in said third operating state, upon a determination by saidfirst processor that (i) said choice represented by said firstadditional vehicle control signal and (ii) said choice represented bysaid internal vehicle control signal, represent a divergent vehiclemanagement control state, wherein said first additional and internalchoices represent substantially different management choices, said firstprocessor is further operative to generate a consultation signalrequesting additional management information, and to cause said firstT/R device to transmit said consultation signal; said first T/R deviceis further operative to transmit said consultation signal; said firstT/R device is further operative to receive a second additional vehiclecontrol signal representing a supplemental vehicle management choice,from a second additional control source; and upon receipt of said secondadditional vehicle control signal, said first processor is furtheroperative to generate said vehicle management signals; whereby thereceipt of signals representing substantially different managementchoices from two sources of vehicle control information results in thesolicitation, by the first processor, of a third source of vehiclecontrol information.
 10. The apparatus defined in claim 9, wherein saiddivergent vehicle management control state is selected from the groupconsisting of (i) two non-equivalent management choices, (ii) at leastone non-numerical management choice, and (iii) two numerical managementchoices wherein a difference between the numerical choices exceeds agiven value.
 11. The apparatus defined in claim 9, wherein said vehiclemanagement signal generated by said first processor represents thesupplemental vehicle management choice.
 12. The apparatus defined inclaim 9, wherein said first processor is operative to compare thevehicle management choice represented by said second additional vehiclecontrol signal, with each of the vehicle management choices representedby said internal and said first additional vehicle control signals; and,upon a determination that the choice represented by said secondadditional vehicle control signal is identical to one of the choicesrepresented by said internal vehicle control signal and said firstadditional vehicle control signal, to generate a vehicle managementsignal representing the supplemental vehicle management choice.
 13. Theapparatus defined in claim 9, wherein said first processor is operativeto compare the vehicle management choice represented by said secondadditional vehicle control signal, with each of the vehicle managementchoices represented by said internal and said first additional vehiclecontrol signals; and, upon a determination that the choice representedby said second additional vehicle control signal is substantiallysimilar to one of the choices represented by said internal vehiclecontrol signal and said first additional vehicle control signal, togenerate a vehicle management signal representing a vehicle managementchoice selected from the group consisting of: the choice represented bysaid second additional vehicle control signal; the choice represented bythe one of (i) the internal vehicle control signal and (ii) the firstadditional vehicle control signal, which is most similar to the choicerepresented by the second additional vehicle control signal.
 14. Theapparatus defined in claim 9, wherein in said third operating state,upon a determination by said first processor that (i) said choicerepresented by said first additional vehicle control signal, (ii) saidchoice represented by said second additional vehicle control signal, and(iii) said choice represented by said internal vehicle control signal,represent a further divergent vehicle management control state, whereinsaid first additional, second additional and internal choices representsubstantially different management choices, said first processor isfurther operative to generate a second consultation signal requestingadditional management information, and to cause said first T/R device totransmit said second consultation signal; said first T/R device isfurther operative to transmit said second consultation signal; saidfirst T/R device is further operative to receive a third additionalvehicle control signal representing a second supplemental vehiclemanagement choice, from a third additional control source; and uponreceipt of said third additional vehicle control signal, said firstprocessor is further operative to generate said vehicle managementsignals; whereby the receipt of signals representing substantiallydifferent management choices from three sources of vehicle controlinformation results in the solicitation, by the first processor, of afourth source of vehicle control information.
 15. The apparatus definedin claim 14, wherein said divergent vehicle management control state isselected from the group consisting of (i) three non-equivalentmanagement choices, (ii) at least one non-numerical management choice,and (iii) three numerical management choices wherein each differencebetween two of the numerical choices exceeds a given value.
 16. Theapparatus defined in claim 1, wherein said SAV is a member of the groupconsisting of: (a) a semi-autonomous automobile; (b) a semi-autonomoustruck; (c) a semi-autonomous rail vehicle; (d) a semi-autonomous ship;(e) a semi-autonomous submarine; (f) a semi-autonomous tank; (g) asemi-autonomous aircraft; and (h) a semi-autonomous space vehicle. 17.The apparatus defined in claim 1, wherein said inputted SAV informationis selected from the group consisting of: (a) vehicle locationinformation, (b) vehicle velocity information, (c) vehicle accelerationinformation, (d) vehicle deceleration information, (e) vehicle attitudeinformation, (f) vehicle rotational information, (g) vehicle GPScoordinates, (h) vehicle fuel reserve information, (i) vehicle batteryinformation, (j) vehicle oil pressure information, (k) vehicle oiltemperature information, (l) vehicle engine temperature information, (m)vehicle tire pressure information, (n) vehicle weight information, (o)vehicle internal pressure, (p) vehicle outside pressure, (q) vehiclevibration information, (r) vehicle rate of ascent, (s) vehicle rate ofdescent, (t) vehicle coolant characteristics, (u) vehicle brake fluidcharacteristics, (v) vehicle transmission fluid characteristics, (w)vehicle communication system characteristics, (x) vehicle windshieldcharacteristics, (y) vehicle camera characteristics, (z) vehicle radarinformation, and (aa) vehicle sonar information.
 18. A method forcontrolling a semi-autonomous vehicle by both an internal and anexternal control source, comprising: (a) receiving, by a vehicleprocessor, vehicle sensor information; (b) based on the received sensorinformation, generating, by the vehicle processor, an internal vehiclecontrol selection, said selection indicating an internal vehiclemanagement choice; (c) transmitting, by the vehicle, the sensorinformation to an additional control source; (d) receiving, by theadditional control source, the sensor information; (e) based on thereceived sensor information, generating, by an additional control sourceprocessor, an external vehicle control selection, said selectionindicating an external vehicle management choice; (f) transmitting bythe additional control source, the external vehicle control selection;(g) receiving, by the vehicle, the external vehicle control selection;(h) receiving, by the vehicle, information specifying one of threeoperating states; (i) based on the received operating state information,selecting, by the vehicle processor, a respective operating state;wherein said operating state determines whether vehicle control is to be(1) determined only by the internal vehicle control selection; (2) onlyby the external vehicle control selection; or (3) by both the internalvehicle control selection and the external vehicle control selection;and (j) based on the selection of said step (i), generating, by thevehicle processor, vehicle control information.
 19. The method of claim18, wherein said step (j) further comprises, upon a selection of saidthird operating state providing vehicle control by both of said internaland external vehicle control selections, upon a determination that saidinternal vehicle control selection comprises a first numerical selectionpertaining to said internal vehicle management choice, and upon adetermination that said external vehicle control selection comprises asecond numerical selection pertaining to said external vehiclemanagement choice; generating, by said vehicle processor, vehiclecontrol information based on a mathematical function of both said firstnumerical selection and said second numerical selection.
 20. The methodof claim 18, wherein said step (j) further comprises, upon a selectionof said third operating state providing vehicle control by both of saidinternal and external vehicle control selections, and upon adetermination that said internal vehicle control selection substantiallydiffers from said external vehicle control selection; (1) transmitting,by the vehicle, the sensor information to a second additional controlsource; (2) receiving, by the second additional control source, thesensor information; (3) based on the received sensor information,generating, by a second additional control source processor, a secondexternal vehicle control selection, said selection indicating a secondexternal vehicle management choice; (4) transmitting by the secondadditional control source, the second external vehicle controlselection; (5) receiving, by the vehicle, the second external vehiclecontrol selection; and (6) generating, by said vehicle processor,vehicle control information based on said internal and external vehiclecontrol selections.
 21. The method of claim 20, wherein said sub-step(6) of said step (j) comprises a management selection, by said vehicleprocessor, from the group comprising: the control choice represented bysaid second external vehicle selection; the control choice representedby a mathematical function of each of the control selection representedby said second external vehicle selection and one of said internalvehicle control selection and said external vehicle control selection;the control choice represented by a mathematical function of each of thecontrol selection represented by said second external vehicle selection,the control selection represented by said internal vehicle controlselection and the control selection represented by said external vehiclecontrol selection.